S i m o n Singh & E d z a r d Ernst
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S i m o n Singh & E d z a r d Ernst
LONDON
•
TORONTO
•
SYDNEY
•
AUCKLAND
•
JOHANNESBURG
61-63 Uxbridge Road, London W5 5SA A Random House Group Company www.mp33pm.com First published in Great Britain in 2008 by Bantam Press an imprint of Transworld Publishers Copyright © Dr Simon Singh and Professor Edzard Ernst 2008 Simon Singh and Edzard Emst have asserted their right under the Copyright, Designs and Patents Act 1988 to be identified as the authors of this work.
Addresses for Random House Group Ltd companies outside the UK can be found a t : w w w . m p 3 3 p m . c o m The Random House Group Ltd Reg. No. 954009 The Random House Group Limited supports The Forest Stewardship Council (FSC), the leading international forest-certification organization. All our titles that are printed on Greenpeace-approved FSC-certified paper carry the FSC logo. Our paper procurement policy can be found at www.mp33pm.com Text design by Julia Lloyd Typeset in Times by Falcon Oast Graphic Art Ltd Printed and bound in Great Britain by Clays Ltd, Bungay, Suffolk
Every effort has been made to obtain the necessary permissions with reference to copyright material, both illustrative and quoted. We apologize for any omissions in this respect and will be pleased to make the appropriate acknowledgements in any future edition.
Contents Introduction
1
1
How Do You Determine the Truth?
6
2
The Truth About Acupuncture
39
3
The Truth About Homeopathy
91
4
The Truth About Chiropractic Therapy
145
§
The Truth About Herbal Medicine
191
(S
Does the Truth Matter?
236
Appendix: Rapid Guide to Alternative Therapies
290
Further Reading
329
Acknowledgements
333
Picture Credits
334
Index
335
Introduction
T H E CONTENTS OF THIS BOOK ARE GUIDED ENTIRELY BY A SINGLE PITHY
sentence, written over 2,000 years ago by Hippocrates of C o s . Recognized as the father of m e d i c i n e , he stated: 'There are,
in fact,
the former begets
two things,
knowledge,
science and opinion;
the
latter ignorance.'
If somebody proposed a n e w medical treatment, then Hippocrates declared that we should use science to decide whether or not it w o r k s , r a t h e r than
relying
on
somebody's
opinion.
Science
employs
e x p e r i m e n t s , observations, trials, argument and discussion in order to arrive at an objective consensus on the truth. Even when a conclusion has been decided, science still probes and prods its o w n proclamations just in case it has m a d e a mistake. In contrast, opinions are subjective and conflicting, and w h o e v e r has the most persuasive PR c a m p a i g n has the best chance of promoting their opinion, regardless of whether they are right or w r o n g . Guided by
Hippocrates' d i c t u m , this b o o k takes a scientific
look at
the current plethora of alternative treatments that are rapidly growing in popularity. These treatments are piled high in every pharmacy, written about in every m a g a z i n e , discussed on millions of w e b pages and used by billions of p e o p l e , yet they are regarded with scepticism by many doctors. Indeed, our definition of an alternative medicine is any therapy that is not accepted by the majority of mainstream doctors, and typically this also means that these alternative therapies have mechanisms that lie outside the current understanding of modern medicine. In the language of science, alternative therapies are said to be biologically implausible. N o w a d a y s it is c o m m o n to hear the umbrella term ' c o m p l e m e n t a r y and alternative m e d i c i n e ' , which correctly implies that sometimes these
therapies
are
used
alongside
and
sometimes
instead of
INTRODUCTION
1
conventional medicine. Unfortunately it is a lengthy and clumsy phrase, so in a bid for simplicity we have decided to use the term 'alternative m e d i c i n e ' throughout this book. Surveys show that in m a n y countries over half the population use alternative medicine in one form or another. Indeed, it is estimated that the annual global spend on all alternative medicines is in the region of £40 billion, making it the fastest-growing area of medical spending. So w h o is right: the critic w h o thinks alternative medicine is akin to voodoo, or the mother who entrusts her child's health to alternative medicine? There are three possible answers. 1
Perhaps alternative medicine is entirely useless. Perhaps persuasive marketing has fooled us into believing that alternative medicine w o r k s . Alternative therapists might seem like nice people, talking as they do about such appealing concepts as 'nature's w o n d e r s ' and 'ancient w i s d o m ' , but they might be misleading the public - or m a y b e they are even deluding themselves. T h e y also use impressive buzzwords like holistic, meridians, self-healing and individualized. If we could see past the jargon, then would we realize that alternative medicine is just a scam?
2
Or m a y b e alternative medicine is overwhelmingly effective. Perhaps the sceptics, including many doctors, have simply failed to recognize the benefits of a more holistic, natural, traditional and spiritual approach to health. Medicine has never claimed to have all the a n s w e r s , and over and over again there have been revolutions in our understanding of the h u m a n body. So will the next revolution lead to a discovery of the mechanisms underlying alternative medicine? Or could there be darker forces at w o r k ? Could it be that the medical establishment wants to maintain its p o w e r and authority, and that doctors criticize alternative medicine in order to quash any rivals? Or might these self-same sceptics be puppets of the big pharmaceutical corporations w h o merely want to hold on to their profits?
3
Or does the truth lie s o m e w h e r e in the middle?
2
TRICK OR TREATMENT?
W h a t e v e r the answer, we decided to write this book in order to get to the truth. Although there are already plenty of books that claim to tell you the truth about alternative m e d i c i n e , we are confident that ours offers an unparalleled level of rigour, authority and independence. We are both trained scientists, so we will e x a m i n e the various alternative therapies in a scrupulous manner. Moreover, neither of us has ever been e m p l o y e d by a pharmaceutical c o m p a n y , and nor have we ever personally profited from the 'natural health' sector - we can honestly say that our only motive is to get to the truth. A n d our partnership brings balance to the book. O n e of u s , Edzard Ernst, is an insider w h o practised medicine for m a n y years, including some alternative therapies. He is the world's first professor of alternative medicine, and his research group has spent fifteen years trying to work out which treatments work and which do not. T h e other of u s , Simon Singh, is an outsider w h o has spent almost t w o decades as a science journalist, working in print, television and r a d i o , always striving to explain complicated ideas in a way that the general public can grasp. Together we think that we can get closer to the truth than anybody else a n d , equally importantly, we will e n d e a v o u r to explain it to you in a clear, vivid and comprehensible manner. O u r mission is to reveal the truth about the potions, lotions, pills, needles, pummelling and energizing that lie beyond the realms of conventional medicine, but which are b e c o m i n g increasingly attractive for many patients. What w o r k s , and what d o e s n ' t ? W h a t are the secrets and what are the lies? W h o is trustworthy and w h o is ripping you off? Do today's doctors k n o w what is best, or do the old w i v e s ' tales indeed tap into some ancient, superior w i s d o m ? All these questions and more will be answered in this b o o k , the world's most honest and accurate examination of alternative medicine. In particular, we will answer the fundamental question: 'Is alternative medicine effective for treating disease?' Although a short and simple question, when unpacked it becomes somewhat complicated and has many answers depending on three key issues. First, which alternative therapy are we talking about? Second, which disease are we applying it to? Third, what is meant by effective? In order to address these questions properly, we have divided the book into six chapters.
INTRODUCTION
3
Chapter 1 provides an introduction to the scientific m e t h o d . It explains h o w scientists, by experimenting and observing, can determine whether or not a particular therapy is effective. Every conclusion we reach in the rest of this book depends on the scientific method and on an unbiased analysis of the best medical research available. S o , by first explaining h o w science w o r k s , we hope to increase your confidence in our subsequent conclusions. Chapter 2 shows h o w the scientific method can be applied to acupuncture, one of the most established, most tested and most widely used alternative therapies. As well as e x a m i n i n g the n u m e r o u s scientific trials that have been conducted on acupuncture, this chapter will also look at its ancient origins in the East, h o w it migrated to the West and h o w it is practised today. Chapters 3 , 4 and 5 use a similar approach to examine the three other major alternative therapies, namely homeopathy, chiropractic therapy and herbal medicine. The remaining alternative therapies will be covered in the appendix, which offers a brief analysis of over thirty treatments. In other words, every alternative therapy that you are ever likely to encounter will be scientifically evaluated within the pages of this book. T h e sixth and final chapter draws some conclusions based on the evidence in the previous chapters and looks ahead to the future of healthcare. If there is o v e r w h e l m i n g evidence that an alternative therapy does not w o r k , then should it be banned or is patient choice the key driving force? On the other hand, if some alternative therapies are genuinely effective, can they be integrated within mainstream medicine or will there always be an antagonism between the establishment and alternative therapists? T h e key theme running throughout all six chapters is ' t r u t h ' . Chapter 1 discusses how science determines the truth. Chapters 2 - 5 reveal the truth about various alternative therapies based on the scientific evidence. Chapter 6 looks at why the truth matters, and h o w this should influence our attitude towards alternative therapies in the context of twenty-first-century medicine. Truth is certainly a reassuring c o m m o d i t y , but in this book it c o m e s with
two
warnings.
First,
we
will
present
the
truth
in
an
unapologetically blunt manner. So where we find that a particular therapy
4
TRICK OR TREATMENT?
does indeed work for a particular illness (e.g. St John's wort does have antidepressive properties, if used appropriately - see Chapter 5), we will say so clearly. In other cases, however, where we discover that a particular therapy is useless, or even harmful, then we shall state this conclusion equally forcefully. You have decided to purchase this book in order to find out the truth, so we think we o w e it to you to be direct and honest. The second warning is that all the truths in this book are based on science, because Hippocrates was absolutely correct when he said that science begets knowledge. Everything we know about the universe, from the components of an atom to the number of galaxies, is thanks to science, and every medical breakthrough, from the development of antiseptics to the eradication of smallpox, has been built upon scientific foundations. Of course, science is not perfect. Scientists will readily admit that they do not know everything, but nevertheless the scientific method is without doubt the best mechanism for getting to the truth. If you are a reader w h o is sceptical about the p o w e r of science, then we kindly request that you at least read Chapter 1. By the end of that first chapter, you should be sufficiently convinced about the value of scientific method that you will consider accepting the conclusions in the rest of the book. It could b e , however, that you refuse to acknowledge that science is the best way to decide whether or not an alternative therapy w o r k s . It might be that you are so close-minded that you will stick to your worldview regardless of what science has to say. You might have an unwavering belief that all alternative medicine is rubbish, or you might adamantly hold the opposite view, that alternative medicine offers a panacea for all our a c h e s , pains and diseases. In either case, this is not the book for you. There is no point in even reading the first chapter if you are not prepared to consider the possibility that the scientific method can act as the arbiter of truth. In fact, if you have already made up your mind about alternative m e d i c i n e , then it would be sensible for you to return this book to the b o o k s h o p and ask for a refund. W h y on Earth would you want to hear about the conclusions of thousands of research studies when you already have all the answers? But our hope is that you will be sufficiently o p e n - m i n d e d to want to read further.
INTRODUCTION
5
How Do You Determine the Truth? 'Truth exists - only lies are invented.'' Georges Braque
THIS
BOOK IS ABOUT ESTABLISHING THE TRUTH IN RELATION TO
alternative medicine. W h i c h therapies work and which ones are u s e less? W h i c h therapies are safe and which ones are dangerous? T h e s e are questions that doctors h a v e asked t h e m s e l v e s for millennia in relation to all forms of m e d i c i n e , and yet it is only c o m paratively recently that they h a v e developed an approach that allows t h e m to separate the effective from the ineffective, and the safe from the dangerous. This approach, k n o w n as evidence-based medicine, has revolutionized medical practice, transforming it from an industry of charlatans and incompetents into a system of healthcare that can deliver such miracles as transplanting k i d n e y s , removing cataracts, c o m b a t i n g c h i l d h o o d d i s e a s e s , eradicating
smallpox and saving
literally millions of lives each year. We will employ the principles of evidence-based medicine to test alternative therapies, so it is crucial that we properly explain what it is and h o w it w o r k s . Rather than introducing it in a modern context, we will go back in time to see h o w it emerged and evolved, which will provide a deeper appreciation of its inherent strengths. In particular, we will look back at how this approach was used to test bloodletting, a bizarre and previously c o m m o n treatment that involved cutting skin and severing blood vessels in order to cure every ailment. T h e b o o m in bloodletting started in Ancient G r e e c e , where it fitted in naturally with the widespread view that diseases were caused by an imbalance of four bodily fluids, otherwise k n o w n as the four humours: blood, yellow bile, black bile and p h l e g m . As well as affecting health, imbalances in these h u m o u r s resulted in particular t e m p e r a m e n t s . B l o o d w a s associated with b e i n g o p t i m i s t i c , y e l l o w bile with being irascible, black bile with being depressed and phlegm with being unemotional. We can still hear the e c h o of h u m o u r i s m in words such as sanguine, choleric, melancholic and phlegmatic.
How
Do You
DETERMINE THE TRUTH?
7
U n a w a r e of h o w blood circulates around the body, Greek physicians believed that it could b e c o m e stagnant and thereby cause ill-health. H e n c e , they advocated the removal of this stagnant blood, prescribing specific procedures for different illnesses. For e x a m p l e , liver problems were treated by tapping a vein in the right hand, whereas ailments relating to the spleen required tapping a vein in the left hand. T h e Greek medical tradition was held in such reverence that bloodletting grew to be a popular method for treating patients throughout Europe in the centuries that followed. Those w h o could afford it would often receive bloodletting from m o n k s in the early M i d d l e A g e s , but then in 1163 Pope Alexander III banned them from practising this gory medical procedure. Thereafter it b e c a m e c o m m o n for barbers to take on the responsibility of being the local bleeder. T h e y took their role very seriously, carefully refining their techniques and adopting new technologies. Alongside the simple blade, there was the phleam, a spring-loaded blade that cut to a particular depth. In later years this was followed by the scarificator, which consisted of a dozen or more spring-loaded blades that simultaneously lacerated the skin. For those barbers w h o preferred a less technological and more natural approach, there was the option of using medicinal leeches. T h e business end of these bloodsucking parasitic w o r m s has three separate j a w s , each one of them carrying about 100 delicate teeth. T h e y offered an ideal method for bloodletting from a patient's g u m s , lips or nose. Moreover, the leech delivers an anaesthetic to reduce pain, an anticoagulant to prevent the blood from clotting, and a vasodilator to expand its victim's blood vessels and increase flow. To enable major bloodsucking
sessions, doctors
would
perform
bdellatomy,
which
involved slicing into the leech so that blood entered its sucker end and then leaked out of the cut. This prevented the leech from b e c o m i n g full and encouraged it to continue sucking. It is often said that t o d a y ' s red-and-white barbershop pole is emblematic of the barber's earlier role as surgeon, but it is really associated with his position as bleeder. T h e red represents the blood, the white is the tourniquet, the ball at the end symbolizes the brass leech basin and the pole itself represents the stick that was squeezed by the patient to increase blood flow.
8
TRICK OR TREATMENT?
M e a n w h i l e , bloodletting was also practised and studied by the most senior medical figures in E u r o p e , such as A m b r o i s e Pare, w h o was the official royal surgeon to four French kings during the sixteenth century. He wrote extensively on the subject, offering lots of useful hints and tips: If the leeches be handled with the bare hand, they are angered, and b e c o m e so stomachfull as that they will not bite; wherefore you shall hold them in a white and clean linen cloth, and apply them to the skin being first lightly scarified, or besmeared with the blood of s o m e other creature, for thus they will take hold of the flesh, together with the skin more greedily and fully. To cause them to fall off, you shall put s o m e powder of A l o e s , salt or ashes upon their heads. If any desire to know how much blood they have drawn, let him sprinkle them with salt made into powder, as soon as they are c o m e off, for thus they will vomit up what blood soever they have sucked.
W h e n Europeans colonized the N e w World, they took the practice of bloodletting with them. American physicians saw no reason to question the techniques taught by the great European hospitals and universities, so they also considered bloodletting to be a mainstream medical procedure that could be used in a variety of circumstances. However, when it was administered to the nation's most important patient in 1799, its use suddenly became a controversial issue. Was bloodletting really a life-saving medical intervention, or was it draining the life out of patients? T h e controversy began on the morning of 13 D e c e m b e r 1799, the day that George Washington a w o k e with the s y m p t o m s of a cold. W h e n his personal secretary suggested that he take some m e d i c i n e , Washington replied, 'You know I never take anything for a cold. I'll let it go just as it c a m e . ' The sixty-seven-year-old former president did not think that a sniffle and a sore throat were anything to worry about, particularly as he had previously suffered and survived far more severe sicknesses. He had contracted smallpox as a teenager, which was followed by a bout of tuberculosis. Next, when he was a young surveyor, he caught
How
Do You
DETERMINE THE T R U T H ?
9
malaria while w o r k i n g in the mosquito-infested s w a m p s of Virginia. T h e n , in 1755, he miraculously survived the Battle of M o n o n g a h e l a , even though t w o horses w e r e killed beneath him and four musket balls pierced his uniform. He also suffered from p n e u m o n i a , was repeatedly afflicted by further bouts of malaria, and developed 'a malignant c a r b u n c l e ' on his hip that incapacitated him for six w e e k s . Perversely, having survived bloody battlefields and dangerous diseases, this apparently minor cold contracted on Friday 13th would prove to be the greatest threat to Washington's life. His condition deteriorated during Friday night, so m u c h so that he a w o k e in the early hours gasping for air. W h e n Mr Albin R a w l i n s , W a s h i n g t o n ' s estate overseer, concocted a mixture of m o l a s s e s , vinegar and butter, he found that his patient could hardly swallow it. R a w l i n s , w h o was also an accomplished bloodletter, decided that further action w a s r e q u i r e d . A n x i o u s to alleviate his m a s t e r ' s s y m p t o m s , he used a surgical knife k n o w n as a lancet to create a small incision in the G e n e r a l ' s arm and r e m o v e d one-third of a litre of blood into a porcelain b o w l . By the morning of 14 December there was still no sign of any improvement, so Martha Washington was relieved when three doctors arrived at the house to take care of her husband. Dr James Craik, the General's personal physician, was accompanied by Dr Gustavus Richard Brown and Dr Elisha Cullen Dick. They correctly diagnosed cynanche trachealis ('dog strangulation'), which we would today interpret as a swelling and inflammation of the epiglottis. This would have obstructed Washington's throat and led to his difficulty in breathing. Dr Craik applied s o m e cantharides (a preparation of dried beetles) to his throat. W h e n this did not have any effect, he opted to bleed the General and r e m o v e d another half a litre of blood. At 11 a.m. he r e m o v e d a similar amount again. T h e average h u m a n body contains only 5 litres of b l o o d , so a significant fraction was being bled from Washington at each session. Dr Craik did not seem concerned. He performed venesection again in the afternoon, r e m o v i n g a further whole litre of blood. Over the next few h o u r s , it appeared that the bloodletting was helping. Washington seemed to recover and for a while he was able to sit
10
TRICK OR TREATMENT?
upright. This w a s , however, merely a temporary remission. W h e n his condition deteriorated again later that day, the doctors conducted yet another session of bloodletting. This time the blood appeared viscous and flowed slowly. F r o m a modern perspective this reflects dehydration and a general loss of bodily fluid caused by excessive blood loss. As the evening passed, the doctors could only watch grimly as their n u m e r o u s bloodlettings and various poultices failed to deliver any signs of recovery. Dr Craick and Dr Dick would later write: ' T h e powers of life seemed n o w manifestly yielding to the force of the disorder. Blisters were applied to the extremities, together with a cataplasm of bran and vinegar to the throat.' George Washington Custis, the dying m a n ' s step-grandson, documented the final m o m e n t s of A m e r i c a ' s first President: As the night advanced it became evident that he was sinking, and he seemed fully aware that 'his hour was nigh'. He inquired the time, and was answered a few minutes to ten. He spoke no more - the hand of death was upon him, and he was conscious that 'his hour was c o m e ' . With surprising self-possession he prepared to die. Composing his form at length and folding his arms on his b o s o m , without a sigh, without a groan, the Father of his Country died. No pang or struggle told when the noble spirit took its noiseless flight; while so tranquil appeared the manly features in the repose of death, that s o m e moments had passed ere those around could believe that the patriarch was no more.
George Washington, a giant m a n of 6 feet 314 inches, had been drained of half his blood in less than a day. T h e doctors responsible for treating Washington claimed that such drastic measures had been necessary as a last-ditch resort to save the patient's life, and most of their colleagues supported the decision. H o w e v e r , there were also voices of dissent from within the medical community. Although bloodletting had been an accepted practice in medicine for centuries, a minority of doctors were now beginning to question its value. Indeed, they argued that bloodletting was a hazard to patients, regardless of where on the body it took place and irrespective of whether it was half
How
Do You
DETERMINE THE TRUTH?
11
a litre or 2 litres that was being taken. According to these doctors, Dr Craik, Dr B r o w n and Dr Dick had effectively killed the former President by needlessly bleeding h i m to death. But w h o was right - the most eminent doctors in the land w h o had done their best to save Washington, or the maverick medics w h o saw bloodletting as a crazy and dangerous legacy of Ancient G r e e c e ? Coincidentally, on the day that Washington died, 14 D e c e m b e r 1799, there was effectively a legal j u d g e m e n t on whether bloodletting was harming or healing patients. T h e j u d g e m e n t arose as the result of an article written by the r e n o w n e d English journalist William Cobbett, w h o was living in Philadelphia and w h o had taken an interest in the activities of a physician by the n a m e of Dr Benjamin R u s h , A m e r i c a ' s most vociferous and famous advocate of bloodletting. Dr Rush was admired throughout A m e r i c a for his brilliant medical, scientific and political career. He had written eighty-five significant publications, including the first A m e r i c a n chemistry textbook; he had been surgeon general of the Continental A r m y ; and, most important of all, he had been a signatory to the Declaration of I n d e p e n d e n c e . Perhaps his achievements were to be expected, bearing in mind that he graduated at the age of just fourteen from the College of N e w Jersey, which later b e c a m e Princeton University. Rush practised at the Pennsylvania Hospital in Philadelphia and taught at its medical school, which was responsible for training threequarters of American doctors during his tenure. He was so respected that he was k n o w n as 'the Pennsylvania H i p p o c r a t e s ' and is still the only physician to have had a statue erected in his h o n o u r in Washington DC by the A m e r i c a n Medical Association. His prolific career had allowed h i m to persuade an entire generation of doctors of the benefits of bloodletting, including the three doctors w h o had attended General Washington. For Rush had served with Dr Craik in the Revolutionary War, he had studied medicine with Dr B r o w n in Edinburgh, and he had taught Dr Dick in Pennsylvania. Dr Rush certainly practised what he preached. His best-documented bloodletting sprees took place during the Philadelphia yellow fever epidemics of 1794 and 1797. He sometimes bled 100 patients in a single day, which meant that his clinic had the stench of stale blood and
12
TRICK OR TREATMENT?
attracted s w a r m s of flies. H o w e v e r , William C o b b e t t , w h o had a particular interest in reporting on medical scandals, w a s convinced that Rush w a s inadvertently killing m a n y of his patients. Cobbett began examining the local bills of mortality and, sure e n o u g h , noticed an increase in death rates after R u s h ' s colleagues followed his r e c o m mendations for bloodletting. This prompted him to declare that R u s h ' s methods had 'contributed to the depopulation of the E a r t h ' . Dr R u s h ' s response to this allegation of malpractice w a s to sue Cobbett for libel in Philadelphia in 1797. Delays and distractions meant that the case dragged on for over t w o years, but by the end of 1799 the jury was ready to m a k e a decision. T h e key issue was whether Cobbett was correct in claiming that Rush was killing his patients through bloodletting, or whether his accusation was unfounded and malicious. While Cobbett could point to the bills of mortality to back up his case, this w a s hardly a rigorous analysis of the impact of bloodletting. Moreover, everything else was stacked against h i m . For e x a m p l e , the trial called just three witnesses, w h o were all doctors sympathetic to Dr Rush's approach to medicine. A l s o , the case w a s argued by seven l a w y e r s , w h i c h suggests that p o w e r s of persuasion were more influential than evidence. R u s h , with his wealth and reputation, had the best lawyers in town arguing his c a s e , so Cobbett was always fighting an uphill battle. On top of all this, the jury was probably also swayed by the fact that Cobbett was not a doctor, whereas Rush was one of the fathers of A m e r i c a n m e d i c i n e , so it would have seemed natural to back R u s h ' s claim. Not surprisingly, Rush w o n the case. Cobbett was ordered to pay $5,000 to Rush in compensation, which was the largest award ever paid out in Pennsylvania. S o , at exactly the same time that George Washington was dying after a series of bloodletting procedures, a court was deciding that it was a perfectly satisfactory medical treatment. We cannot, however, rely on an eighteenth-century court to decide whether or not the medical benefits of bloodletting outweigh any d a m a g i n g side-effects. After all, the j u d g e m e n t was probably heavily biased by all the factors already mentioned. It is also worth r e m e m bering that Cobbett was a foreigner, whereas Rush was a national hero, so a j u d g e m e n t against Rush was almost unthinkable.
How Do You DETERMINE THE TRUTH?
13
In order to decide the true value of bloodletting, the medical profession would require a more rigorous procedure, something even less biased than the fairest court imaginable. In fact, while Rush and Cobbett were debating medical matters in a court of law, they were unaware that exactly the right sort of procedure for establishing the truth about medical matters had already been discovered on the other side of the Atlantic and was being used to great effect. Initially it was used to test a radically new treatment for a disease that afflicted only sailors, but it would soon be used to evaluate bloodletting, and in time this approach would be brought to bear on a whole range of medical interventions, including alternative therapies.
Scurvy, limeys and the blood test In June 1744 a hero of the British navy n a m e d C o m m a n d e r George Anson returned h o m e having completed a circumnavigation of the world that had taken almost four years. Along the way, Anson had fought and captured the Spanish galleon Covadonga, including its 1,313,843 pieces of eight and 35,682 ounces of virgin silver, the most valuable prize in E n g l a n d ' s decade of fighting against Spain. W h e n Anson and his m e n paraded through L o n d o n , his booty accompanied him in thirty-two w a g o n s filled with bullion. Anson had, however, paid a high price for these spoils of war. His crew had been repeatedly struck by a disease k n o w n as scurvy, which had killed more than two out of three of his sailors. To put this into context, while only four men had been killed d u r i n g A n s o n ' s naval b a t t l e s , o v e r
1,000 had
succumbed to scurvy. Scurvy had been a constant curse ever since ships had set sail on voyages lasting for more than just a few w e e k s . T h e first recorded case of naval scurvy was in 1497 as Vasco da G a m a rounded the Cape of G o o d H o p e , and thereafter the incidences increased as e m b o l d e n e d captains sailed further across the globe. T h e English surgeon William C l o w e s , w h o had served in Q u e e n Elizabeth's fleet, gave a detailed description of the horrendous s y m p t o m s that would eventually kill two million sailors:
14
TRICK OR TREATMENT?
Their gums were rotten even to the very roots of their very teeth, and their cheeks hard and swollen, the teeth were loose neere ready to fall out . . . their breath a filthy savour. The legs were feeble and so weak, that they were full of aches and paines, with many blewish and reddish staines or spots, s o m e broad and s o m e small like flea-biting.
All this m a k e s sense from a modern point of view, because we k n o w that scurvy is the result of vitamin C deficiency. T h e h u m a n body uses vitamin C to produce collagen, which glues together the b o d y ' s m u s c l e s , blood vessels and other structures, and so helps to repair cuts and bruises. H e n c e , a lack of vitamin C results in bleeding and the decay of cartilage, ligaments, t e n d o n s , b o n e , skin, g u m s and teeth. In short, a scurvy patient disintegrates gradually and dies painfully. The term ' v i t a m i n ' describes an organic nutrient that is vital for survival, but which the body cannot produce itself; so it has to be supplied through food. We typically obtain our vitamin C from fruit, something that was sadly lacking from the average sailor's diet. Instead, sailors ate biscuits, salted meat, dried fish, all of which were devoid of vitamin C and likely to be riddled with weevils. In fact, infestation was generally considered to be a good sign, because the weevils would abandon the meat only when it b e c a m e dangerously rotten and truly inedible. The simple solution would have been to alter the sailors' diet, but scientists had yet to discover vitamin C and were unaware of the importance of fresh fruit in preventing scurvy. Instead, physicians proposed a whole series of other remedies. Bloodletting, of course, was always worth a try, and other treatments included the consumption of mercury paste, salt water, vinegar, sulphuric acid, hydrochloric acid or Moselle wine. Another treatment required burying the patient up to his neck in sand, which was not even very practical in the middle of the Pacific. The most twisted remedy was hard labour, because doctors observed that scurvy was generally associated with lazy sailors. Of course, the doctors had confused cause and effect, because it was scurvy that caused sailors to be lazy, rather than laziness that made sailors vulnerable to scurvy. This array of pointless remedies meant that maritime ambitions during the seventeenth and eighteenth centuries continued to be
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blighted by deaths from scurvy. Learned m e n around the world would fabricate arcane theories about the causes of scurvy and debate the merits of various c u r e s , but nobody seemed capable of stopping the rot that was killing hundreds of thousands of sailors. T h e n , in 1746, there c a m e a major breakthrough w h e n a y o u n g Scottish naval surgeon called James Lind boarded H M S Salisbury. His sharp brain and meticulous mind allowed him to discard fashion, prejudice, anecdote and hearsay, and instead he tackled the curse of scurvy with extreme logic and rationality. In short, J a m e s Lind was destined to succeed where all others had failed because he implemented what seems to have been the w o r l d ' s first controlled clinical trial. L i n d ' s tour of duty took him around the English Channel and Mediterranean, and even though H M S Salisbury never strayed far from land, one in ten sailors showed signs of scurvy by the spring of 1747. L i n d ' s first instinct was probably to offer sailors one of the many treatments popular at the time, but this was overtaken by another thought that crossed his m i n d . W h a t would happen if he treated different sailors in different w a y s ? By observing w h o recovered and w h o deteriorated he would be able to determine which treatments were effective and which were useless. To us this m a y seem o b v i o u s , but it was a
truly
radical
departure
from
previous medical c u s t o m . On 20 M a y Lind identified twelve sailors with similarly serious s y m p t o m s of scurvy, inasmuch
as
they
all
had
'putrid g u m s , the spots and lassitude, with weakness of their k n e e s ' . He then placed their h a m m o c k s in the same portion of the ship and ensured that they all received the same breakfast, thereby James Lind
16
TRICK OR TREATMENT?
lunch
establishing
and
dinner,
'one
diet
c o m m o n to a l l ' . In this way, Lind w a s
helping to guarantee a fair test because all the patients w e r e similarly sick, similarly housed and similarly fed. He then divided the sailors into six pairs and gave each pair a different treatment. T h e first pair received a quart of cider, the second pair received twenty-five drops of elixir of vitriol (sulphuric acid) three times a day, the third pair received t w o spoonfuls of vinegar three times a day, the fourth pair received half a pint of sea water a day, the fifth pair received a medicinal paste consisting of garlic, m u s t a r d , radish root and g u m m y r r h , and the sixth pair received t w o oranges and a lemon each day. A n o t h e r g r o u p of sick sailors w h o continued with the normal naval diet w e r e also monitored and acted as a control g r o u p . There are t w o important points to clarify before m o v i n g on. First, the inclusion of oranges and lemons was a shot in the dark. Although there had been a few reports of l e m o n s relieving s y m p t o m s of scurvy as far back as
1 6 0 1 , late-eighteenth-century doctors would have
viewed fruit as a bizarre remedy. Had the term 'alternative m e d i c i n e ' existed in L i n d ' s era, then his colleagues might have labelled oranges and lemons as alternative, as they were natural remedies that were not backed by a plausible theory, and thus they were unlikely to c o m p a r e well against the more established medicines. T h e second important point is that Lind did not include bloodletting in his trial. Although others may have felt that bloodletting was appropriate for treating scurvy, Lind was unconvinced and instead he suspected that the genuine cure would be related to diet. We shall return to the question of testing bloodletting shortly. T h e clinicial trial began and Lind waited to see which sailors, if any, would recover. Although the trial was supposed to last fourteen d a y s , the ship's supply of citrus fruits c a m e to an end after just six d a y s , so Lind had to evaluate the results at this early stage. Fortunately, the conclusion was already o b v i o u s , for the sailors w h o were c o n s u m i n g lemons and oranges had m a d e a remarkable and almost complete recovery. All the other patients were still suffering from scurvy, except for the cider drinkers w h o showed slight signs of improvement. This is probably because cider can also contain small amounts of vitamin C, depending on h o w it is m a d e .
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By controlling variables such as environment and diet, Lind had demonstrated that oranges and lemons were the key to curing scurvy. Whilst the numbers of patients involved in the trial were extremely small, the results he obtained were so striking that he was convinced by the findings. He had no idea, of course, that oranges and lemons contain vitamin C, or that vitamin C is a key ingredient in the production of collagen, but n o n e of this was important - the bottom line was that his treatment led to a cure. Demonstrating that a treatment is effective is the number-one priority in medicine; understanding the exact details of the underlying m e c h a n i s m can be left as a problem for subsequent research. Had Lind been researching in the twenty-first century, he would have reported his findings at a major conference and subsequently published them in a medical journal. Other scientists would have read his methodology and repeated his trial, and within a year or t w o there would have been an international consensus on the ability of oranges and lemons to cure scurvy. Unfortunately, the eighteenth-century medical c o m m u n i t y was comparatively splintered, so new breakthroughs were often overlooked. Lind himself did not help matters because he was a diffident m a n , w h o failed to publicize and promote his research. Eventually, six years after the trial, he did write up his work in a book dedicated to C o m m a n d e r A n s o n , w h o had famously lost over 1,000 m e n to scurvy just a few years earlier. Treatise on the Scurvy was an intimidating tome consisting of 4 0 0 pages written in a plodding style, so not surprisingly it w o n him few supporters. Worse still, Lind undermined the credibility of his cure with his development of a concentrated version of lemon j u i c e that would be easier to transport, store, preserve and administer. This so-called rob was created by heating and evaporating lemon j u i c e , but Lind did not realize that this process destroyed vitamin C, the active ingredient that cured scurvy. Therefore, anybody w h o followed L i n d ' s r e c o m m e n d ation soon b e c a m e disillusioned, because the lemon rob was almost totally ineffective. S o , despite a successful trial, the simple lemon cure was ignored, scurvy continued unabated and m a n y more sailors died. By the time that the Seven Years War with France had ended in 1763,
18
TRICK OR TREATMENT?
the tallies showed that 1,512 British sailors had been killed in action and 100,000 had been killed by scurvy. H o w e v e r , in 1780, thirty-three years after the original trial, L i n d ' s work caught the eye of the influential physician Gilbert Blane. N i c k n a m e d 'Chillblain' because of his frosty demeanour, Blane had stumbled upon L i n d ' s treatise on scurvy while he was preparing for his first naval posting with the British fleet in the Caribbean. He was impressed by L i n d ' s declaration that he would ' p r o p o s e nothing dictated merely from theory; but shall confirm all by experience and facts, the surest and most unerring g u i d e s ' . Inspired by L i n d ' s approach and interested in his conclusion, Blane decided that he would scrupulously monitor mortality rates throughout the British fleet in the West Indies in order to see what would happen if he introduced lemons to the diet of all sailors. Although Blane's study was less rigorously controlled than Lind's research, it did involve a m u c h larger n u m b e r of sailors and its results were arguably even more striking. During his first year in the West Indies there were 12,019 sailors in the British fleet, of w h o m only sixty died in combat and a further 1,518 died of disease, with scurvy accounting for the overwhelming majority of these deaths. H o w e v e r , after Blane introduced lemons into the diet, the mortality rate was cut in half. Later, limes were often used instead of l e m o n s , which led to limeys as a slang term for British sailors and later for Brits in general. Not only did Blane b e c o m e convinced of the importance of fresh fruit, but fifteen years later he w a s able to i m p l e m e n t scurvy prevention throughout the British fleet w h e n he was appointed to the Sick and Hurt Board, which was responsible for determining naval medical procedures. On 5 M a r c h 1795 the Board and the Admiralty agreed that sailors' lives would be saved if they were issued a daily ration of just three-quarters of an ounce of lemon j u i c e . Lind had died just one year earlier, but his mission to rid British ships of scurvy had been ably completed by B l a n e . T h e British had been tardy in adopting lemon therapy, as almost half a century had passed since L i n d ' s groundbreaking trial, but many other nations were even tardier. This gave Britain a huge advantage in terms of colonizing distant lands and winning sea battles with its E u r o p e a n
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neighbours. For e x a m p l e , prior to the Battle of Trafalgar in 1805, Napoleon had planned to invade Britain, but he was prevented from doing so by a British naval blockade that trapped his ships in their h o m e ports for several m o n t h s . Bottling up the French fleet was possible only because the British ships supplied their crews with fruit, which meant that they did not have to interrupt their tour of duty to bring on board new healthy sailors to replace those that would have been dying from scurvy. Indeeed, it is no exaggeration to say that L i n d ' s invention of the clinical trial and Blane's consequent promotion of lemons to treat scurvy saved the nation, because N a p o l e o n ' s army was m u c h stronger than its British counterpart, so a failed blockade would probably have resulted in a successful French invasion. T h e fate of a nation is of major historic importance, yet the application of the clinical trial would have even greater significance in the centuries ahead. Medical researchers would go on to use clinical trials routinely to decide which treatments worked and which were ineffective. In turn, this w o u l d allow doctors to save hundreds of millions of lives around the world because they would be able to cure diseases by confidently relying on proven medicines, rather than mistakenly advocating quack r e m e d i e s . Bloodletting, because of its central role in m e d i c i n e , was one of the first treatments to be submitted to testing via the controlled clinical trial. In 1809, just a d e c a d e after Washington had undergone bloodletting on his deathbed, a Scottish military surgeon called Alexander Hamilton set out to determine whether or not it was advisable to bleed patients. Ideally, his clinical trial would have e x a m i n e d the impact of bloodletting on a single disease or s y m p t o m , such as gonorrhoea or fever, because the results tend to be clearer if a trial is focused on one treatment for one ailment. H o w e v e r , the trial took place while Hamilton was serving in the Peninsular War in Portugal, where battlefield conditions did not afford him the luxury of conducting an ideal trial - instead, he examined the impact of bloodletting on a broad range of conditions. To be fair to Hamilton, this was not such an unreasonable design for his trial, because at the time bloodletting w a s touted as a p a n a c e a - if p h y s i c i a n s believed that bloodletting could cure every d i s e a s e , then it could be argued
20
TRICK OR TREATMENT?
that the trial should include patients with every disease. Hamilton began his trial by dividing a sample of 366 soldiers with a variety of medical problems into three groups. T h e first t w o groups were treated by himself and a colleague ( M r Anderson) without resorting to bloodletting, whereas the third group w a s treated by an u n n a m e d doctor w h o administered the usual treatment of e m p l o y i n g a lancet to bleed his patients. T h e results of the trial were clear: It had been so arranged, that this number was admitted, alternately, in such a manner that each of us had one third of the whole. The sick were indiscriminately received, and were attended as nearly as possible with the same care and accommodated with the same comforts . . . Neither Mr Anderson nor I ever once employed the lancet. He lost two, I four cases; whilst out of the other third thirty-five patients died.' T h e death rate for patients treated with bloodletting was ten times greater than for those patients w h o avoided bloodletting. This w a s a damning indictment on drawing blood and a vivid demonstration that it caused death rather than saved lives. It would have been hard to argue with the trial's conclusion, because it scored highly in terms of two of the main factors that determine the quality of a trial. First, the trial was carefully controlled, which m e a n s that the separate groups of patients were treated similarly except for one particular factor, namely bloodletting. This allowed Hamilton to isolate the impact of bloodletting. Had the bloodletting group been kept in poorer conditions or given a different diet, then the higher death rate could have been attributed to environment or nutrition, but Hamilton had ensured that all the groups received the ' s a m e c a r e ' and ' s a m e c o m f o r t s ' . Therefore bloodletting alone could be identified as being responsible for the higher death rate in the third g r o u p . Second, Hamilton had tried to ensure that his trial was fair by guaranteeing that the groups that w e r e being studied were on average as similar as possible. He achieved this by avoiding any systematic assignment of patients, such as deliberately steering elderly soldiers towards the bloodletting g r o u p , which would have biased the trial against bloodletting. Instead, Hamilton assigned patients to each group
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'alternately'
and
'indiscriminately', which today
is
known
as
randomizing the allocation of treatments in a trial. If the patients are randomly assigned to g r o u p s , then it can be assumed that the groups will be broadly similar in terms of any factor, such as age, i n c o m e , gender or the severity of the illness, which might affect a patient's outc o m e . Randomization even allows for u n k n o w n factors to be balanced equally across the g r o u p s . Fairness through randomization is particularly effective if the initial pool of participants is large. In this case, the n u m b e r of participants (366 patients) was impressively large. Today medical researchers call this a randomized controlled trial (or R C T ) or a randomized clinical trial, and it is considered the gold standard for putting therapies to the test. Although Hamilton succeeded in conducting the first randomized clinical trial on the effects of bloodletting, he failed to publish his results. In fact, we k n o w of H a m i l t o n ' s research only because his documents w e r e rediscovered in 1987 a m o n g papers hidden in a trunk lodged with the Royal College of Physicians in Edinburgh. Failure to publish is a serious dereliction of duty for any medical researcher, because publication has t w o important c o n s e q u e n c e s . First, it encourages others to replicate the research, which might either reveal errors in the original research or confirm the result. Second, publication is the best way to disseminate new research, so that others can apply what has been learned. Lack of publication meant that H a m i l t o n ' s bloodletting trial had no impact on the widespread enthusiasm for the practice. Instead, it would take a few more years before other medical pioneers, such as the French doctor Pierre L o u i s , would conduct their o w n trials and confirm Hamilton's
conclusion. These
results, which
were
properly
published and disseminated, repeatedly showed that bloodletting was not a lifesaver, but rather it was a potential killer. In light of these findings, it seems highly likely that bloodletting was largely responsible for the death of George Washington. Unfortunately, because these anti-bloodletting conclusions were contrary to the prevailing view, many doctors struggled to accept them and even tried their best to undermine them. For e x a m p l e , when Pierre Louis published the results of his trials in
22
TRICK OR TREATMENT?
1828, m a n y doctors
dismissed his negative conclusion about bloodletting precisely because it was based on the data gathered by analysing large n u m b e r s of patients. T h e y slated his so-called 'numerical m e t h o d ' because they were m o r e interested in treating the individual patient lying in front of t h e m than in what might happen to a large sample of patients. Louis responded by arguing that it was impossible to k n o w whether or not a treatment might be safe and effective for the individual patient unless it had been demonstrated to be safe and effective for a large n u m b e r of patients: 'A therapeutic agent cannot be e m p l o y e d with any discrimination or probability of success in a given c a s e , unless its general efficacy, in analogous c a s e s , has been previously ascertained . .. without the aid of statistics nothing like real medicine is possible.' And when the Scottish doctor Alexander MacLean advocated the use of medical trials to test treatments while he was working in India in 1818, critics argued that it was wrong to experiment with the health of patients in this way. He responded by pointing out that avoiding trials would mean that medicine would for ever be nothing more than a collection of untested treatments, which might be wholly ineffective or dangerous. He described medicine practised without any evidence as 'a continued series of experiments upon the lives of our fellow creatures.' Despite the invention of the clinical trial and regardless of the evidence against bloodletting, many European doctors continued to bleed their patients, so m u c h so that France had to import 42 million leeches in 1833. But as each decade passed, rationality began to take hold a m o n g doctors, trials b e c a m e more c o m m o n , and dangerous and useless therapies such as bloodletting began to decline. Prior to the clinical trial, a doctor decided his treatment for a particular patient by relying on his o w n prejudices, or on what he had been taught by his peers, or on his m i s r e m e m b e r e d experiences of dealing with a handful of patients with a similar condition. After the advent of the clinical trial, doctors could choose their treatment for a single patient by examining the evidence from several trials, perhaps involving thousands of patients. There was still no guarantee that a treatment that had succeeded during a set of trials would cure a particular patient, but any doctor w h o adopted this approach was giving his patient the best possible chance of recovery.
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L i n d ' s invention of the clinical trial had triggered a gradual revolution that gained m o m e n t u m during the course of the nineteenth century. It transformed medicine from a d a n g e r o u s lottery in the eighteenth century into a rational discipline in the twentieth century. T h e clinical trial helped give birth to m o d e r n m e d i c i n e , which has enabled us to live longer, healthier, happier lives.
Evidence-based medicine Because clinical trials are an important factor in determining the best treatments for patients, they have a central role within a m o v e m e n t k n o w n as evidence-based medicine. Although the core principles of evidence-based medicine w o u l d have been appreciated by J a m e s Lind back in the eighteenth century, the m o v e m e n t did not really take hold until the mid-twentieth century, and the t e i m itself did not appear in print until 1992, w h e n it was coined by David Sackett at M c M a s t e r University, Ontario. He defined it thus: 'Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.' Evidence-based medicine e m p o w e r s doctors by providing them with the most reliable information, and therefore it benefits patients by increasing the likelihood that they will receive the most appropriate treatment. From a twenty-first-century perspective, it seems obvious that medical decisions should be based on e v i d e n c e , typically from randomized clinical trials, but the e m e r g e n c e of evidence-based medicine marks a turning point in the history of m e d i c i n e . Prior to the d e v e l o p m e n t of evidence-based m e d i c i n e , doctors were spectacularly ineffective. T h o s e patients w h o recovered from disease were usually successful despite the treatments they had received, not because of them. But once the medical establishment had adopted such simple ideas as the clinical trial, then progress b e c a m e swift. Today the clinical trial is routine in the development of n e w treatments and medical experts agree that evidence-based medicine is the key to effective healthcare. H o w e v e r , people outside the medical establishment sometimes find the concept of evidence-based medicine cold, confusing and
24
TRICK^ OR TREATMENT?
intimidating. If you have any sympathy with this point of view, then, once again, it is worth r e m e m b e r i n g what the world was like before the advent of the clinical trial and evidence-based medicine: doctors were oblivious to the h a r m they caused by bleeding millions of p e o p l e , indeed killing m a n y of t h e m , including George Washington. T h e s e doctors were not stupid or evil; they merely lacked the k n o w l e d g e that emerges when medical trials flourish. Recall Benjamin R u s h , for e x a m p l e , the prolific bleeder w h o sued for libel and w o n his case on the day that Washington died. He was a brilliant, well-educated m a n and a compassionate o n e , w h o was responsible for recognizing addiction as a medical condition and realizing that alcoholics lose the capacity to control their drinking behaviour. He was also an advocate for w o m e n ' s rights, fought to abolish slavery and c a m p a i g n e d against capital punishment. H o w e v e r , this combination of intelligence and decency was not e n o u g h to stop him from killing hundreds of patients by bleeding t h e m to death, and encouraging m a n y of his students to do exactly the s a m e . Rush was fooled by his respect for ancient ideas coupled with the ad hoc reasons that were invented to justify the use of bloodletting. For e x a m p l e , it would have been easy for Rush to mistake the sedation caused by bloodletting for a genuine i m p r o v e m e n t , unaware that he was draining the life out of his patients. He was also probably confused by his o w n m e m o r y , selectively r e m e m b e r i n g those of his patients w h o survived b l e e d i n g and c o n v e n i e n t l y
forgetting
those
w h o died.
Moreover, Rush would have been tempted to attribute any success to his treatment and to dismiss any failure as the fault of a patient w h o in any case was destined to die. Although evidence-based medicine n o w c o n d e m n s the sort of bloodletting that Rush indulged in, it is important to point out that evidence-based medicine also means remaining open to new evidence and revising conclusions. For e x a m p l e , thanks to the latest evidence from new trials, bloodletting is o n c e again an acceptable treatment in very specific situations - it has n o w been demonstrated, for instance, that bloodletting as a last resort can ease the fluid overload caused by heart failure. Similarly, there is n o w a role for leeches in helping patients recover from some forms of surgery. For e x a m p l e , in 2007 a
How Do You DETERMINE THE TRUTH?
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w o m a n in Yorkshire had leeches placed in her mouth four times a day for a week and a half after having a cancerous t u m o u r r e m o v e d and her tongue reconstructed. This was because leeches release chemicals that increase blood flow and thus accelerate healing. Despite
being
an
u n d o u b t e d force for g o o d , e v i d e n c e - b a s e d
medicine is occasionally treated with suspicion. S o m e people perceive it as being a strategy for allowing the medical establishment to defend its o w n m e m b e r s and their treatments, while excluding outsiders w h o offer alternative treatments. In fact, as we have seen already, the o p p o site is often true, because evidence-based medicine actually allows outsiders to be heard - it endorses any treatment that turns out to be effective, regardless of w h o is behind it, and regardless of h o w strange it might appear to b e . L e m o n juice as a treatment for scurvy was an implausible remedy, but the establishment had to accept it because it w a s backed up by evidence from trials. Bloodletting, on the other hand, was very m u c h a standard treatment, but the establishment eventually had to reject its o w n practice because it was undermined by evidence from trials. There is one episode from the history of medicine that illustrates particularly well h o w an evidence-based approach forces the medical establishment to accept the conclusions that emerge when medicine is put to the test. Florence Nightingale, the Lady with the L a m p , was a w o m a n with very little reputation, but she still managed to win a bitter argument against the
male-dominated
medical establishment by
arming herself with solid, irrefutable data. Indeed, she can be seen as one of the earliest advocates of evidence-based m e d i c i n e , and she successfully used it to transform Victorian healthcare. Florence and her sister were born during an extended and very productive two-year-long
Italian h o n e y m o o n taken by their parents
William and Frances Nightingale. Florence's older sister was born in 1819 and named Parthenope after the city of her birth - Parthenope being the Greek n a m e for N a p l e s . Then Florence was born in the spring of 1820, and she too was named after the city of her birth. It was expected that Florence Nightingale would grow up to live the life of a privileged English Victorian lady, but as a teenager she regularly claimed to hear G o d ' s voice guiding her. H e n c e , it seems that her
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TRICK OR TREATMENT?
desire to b e c o m e a nurse was the result of a 'divine c a l l i n g ' . This distressed her parents, because nurses were generally viewed as being poorly educated, promiscuous and often drunk, but these were exactly the prejudices that Florence was determined to crush. T h e prospect of Florence nursing in Britain was already shocking e n o u g h , so her parents would have been doubly terrified by her subsequent decision to work in the hospitals of the C r i m e a n War. Florence had read scandalous reports in newspapers such as The Times, which highlighted the large n u m b e r of soldiers w h o were succumbing to cholera and malaria. She volunteered her services, and by N o v e m b e r 1854 Florence was running the Scutari Hospital in Turkey, which w a s notorious for its filthy w a r d s , dirty b e d s , blocked sewers and rotten food. It soon b e c a m e clear to her that the main cause of death was not the w o u n d s suffered by the soldiers, but rather the diseases that ran rife under such squalid conditions. As one official report admitted, ' T h e wind blew sewer air up the pipes of n u m e r o u s open privies into the corridors and wards where the sick were lying.' Nightingale set about transforming the hospital by providing decent food, clean linen, clearing out the drains and opening the w i n d o w s to let in fresh air. In just one week she r e m o v e d 215 handcarts of filth, flushed the sewers nineteen times and buried the carcasses of t w o horses, a cow and four dogs which had been found in the hospital g r o u n d s . T h e officers and doctors w h o had previously run the institution felt that these changes were an insult to their professionalism and fought her every step of the way, but she pushed ahead regardless. T h e results seemed to vindicate her methods: in February 1855 the death rate for all admitted soldiers was 43 per cent, but after her reforms it fell dramatically to just 2 per cent in June 1855. W h e n she returned to Britain in the s u m m e r of 1856, Nightingale was greeted as a h e r o , in large part due to The Times'?, support:
Wherever there is disease in its most dangerous form, and the hand of the spoiler distressingly nigh, there is that incomparable woman sure to be seen; her benignant presence is an influence for good comfort even amid the struggles of expiring nature. She is a 'ministering angel' without any exaggeration in these hospitals, and, as her slender form glides
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quietly along each corridor, every fellow's face softens with gratitude at the sight of her.
H o w e v e r , there were still many sceptics. T h e principal medical officer of the army argued that Nightingale's higher survival rates were not necessarily due to her improved hygiene. He pointed out that her apparent success might have been due to treating soldiers with less serious w o u n d s , or m a y b e they were treated during a period of milder weather, or m a y b e there was some other factor that had not been taken into account. Fortunately, as well as being an exceptionally dedicated military nurse, Nightingale w a s also a brilliant statistician. H e r father, William Nightingale, had been b r o a d m i n d e d enough to believe that w o m e n should be properly educated, so Florence had studied Italian, Latin, Greek, history, and particularly mathematics. In fact, she had received tutoring from some of Britain's finest mathematicians, such as J a m e s Sylvester and Arthur Cayley. S o , when she was challenged by the British establishment, she drew upon this mathematical training and used statistical arguments to back her c l a i m that i m p r o v e d h y g i e n e
led to higher survival
rates.
Nightingale had scrupulously compiled detailed records of her patients throughout her time in the C r i m e a , so she was able to trawl through them and find all sorts of evidence that proved that she was right about the importance of hygiene in healthcare. For e x a m p l e , to show that the filth at Scutari Hospital had been killing soldiers, she used her records to c o m p a r e a group of soldiers treated at Scutari in the early unhygienic days with a control group of injured soldiers w h o at the same time were being kept at their own army c a m p . If the camp-based control group fared better than the Scutari g r o u p , then this would indicate that the conditions that Nightingale encountered when she arrived at Scutari were indeed doing more harm than g o o d . Sure e n o u g h , the camp-based soldiers had a mortality rate of 27 deaths per 1,000 compared with 4 2 7 per 1,000 at Scutari. This was only one set of statistics, but when put alongside other comparisons it helped Nightingale to win her argument about the importance of hygiene.
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TRICK OR TREATMENT?
Nightingale was convinced that all other major medical decisions ought to be based on similar sorts of e v i d e n c e , so she fought for the establishment of a Royal C o m m i s s i o n on the Health of the A r m y , to which
she
herself submitted
several
hundred
pages of detailed
statistics. At a time when it was considered radical merely to include data tables, she also drew multicoloured diagrams that would not look out of place in a modern b o a r d r o o m presentation. She even invented an elaborate version of the pie chart, k n o w n as the polar area chart, which helped to illustrate her data. She realized that illustrating her statistics w o u l d be enormously helpful in selling her argument to politicians, w h o were usually not well versed in m a t h e m a t i c s . In due c o u r s e , Nightingale's statistical studies spearheaded a revolution in a r m y hospitals, because the Royal C o m m i s s i o n ' s report led to the establishment of an A r m y Medical School and a system of collecting medical records. In turn, this resulted in a careful monitoring of which conditions and treatments did and did not benefit patients. Today, Florence Nightingale is best k n o w n as the founder of modern nursing, having established a curriculum and training college for nurses. H o w e v e r , it can be argued that her lifelong c a m p a i g n i n g for health reforms based on statistical evidence had an even more significant impact on healthcare. She was elected the first female m e m b e r of the Royal Statistical Society in 1858, and went on to b e c o m e an honorary m e m b e r of the American Statistical Association. Nightingale's passion for statistics enabled her to persuade the government of the importance of a whole series of health reforms. For e x a m p l e , m a n y people had argued that training nurses was a waste of time, because patients cared for by trained nurses actually had a higher mortality rate than those treated by untrained staff. Nightingale, h o w ever, pointed out that this was only because more serious cases were being sent to those wards with trained nurses. If the intention is to c o m p a r e the results from two g r o u p s , then it is essential (as discussed earlier) to assign patients randomly to the t w o g r o u p s . Sure e n o u g h , when Nightingale set up trials in which patients were randomly assigned to trained and untrained nurses, it b e c a m e clear that the cohort of patients treated by trained nurses fared much better than their counterparts in wards with untrained nurses. Furthermore, Nightingale used
How
Do You
DETERMINE THE TRUTH?
29
Florence Nightingale's polar chart showing 'Mortality of the Army in the East', April 1854-March 1855.
statistics to show that home births were safer than hospital births, presumably because British homes were cleaner than Victorian hospitals. Her interests also ranged overseas, because she also used mathematics to study the influence of sanitation on healthcare in rural India. A n d throughout her long career, Nightingale's c o m m i t m e n t to working with soldiers never w a n e d . In one of her later studies, she observed that soldiers based in Britain in peacetime had an annual mortality rate of 20 per 1,000, nearly twice that of civilians, which she suspected was due to poor conditions in their barracks. She calculated the death toll across the whole British army due to poor a c c o m m o d a t i o n and then m a d e a c o m m e n t that highlighted h o w this was such a needless waste of young lives: 'You might as well take 1,100 men every year out upon Salisbury Plain and shoot t h e m . ' T h e lesson to be learned from Florence Nightingale's medical triumphs is that scientific testing is not just the best way to establish truth in medicine, but it is also the best m e c h a n i s m for having that truth
30
TRICK OR TREATMENT?
recognized. T h e results from scientific tests are so powerful that they even enable a relative u n k n o w n such as Nightingale - a y o u n g w o m a n , not part of the establishment, without a great reputation - to prove that she is right and that those in p o w e r are w r o n g . Without medical testing, lone visionaries such as Nightingale would be ignored, while doctors would continue to operate according to a corrupt b o d y of medical k n o w l e d g e b a s e d merely o n tradition, d o g m a , fashion, politics, marketing and a n e c d o t e .
A stroke of genius Before applying an evidence-based approach to evaluating alternative medicine, it is worth r e - e m p h a s i z i n g that it provides extraordinarily powerful and persuasive c o n c l u s i o n s . Indeed, it is not just the medical establishment that has to t u g its forelock in the face of evidence-based m e d i c i n e , because g o v e r n m e n t s can also be forced to change their policies and corporations m a y have to alter their products according to what the scientific evidence s h o w s . O n e final story illustrates exactly how scientific evidence c a n m a k e the world sit u p , listen and act regarding health issues - it concerns the research that dramatically revealed the previously u n k n o w n dangers of s m o k i n g . This research was c o n d u c t e d by Sir Austin Bradford Hill and Sir Richard Doll, w h o had curiously mirrored each other in their backgrounds. Hill had wanted to follow in his father's footsteps and b e c o m e a doctor, but a b o u t of tuberculosis made this impossible, so instead he pursued a more mathematical career. Doll's ambition was to study mathematics at C a m b r i d g e , but he got drunk on three pints of Trinity Audit Ale (8 per cent alcohol) the night before his entrance e x a m and underperformed, so instead he pursued a career in m e d i c i n e . T h e result was a pair of m e n with strong interests in both healthcare and statistics. Hill's career had involved research into a wide variety of health issues. In the 1940s, for instance, he demonstrated a link between arsenic and cancer in chemical workers by examining death certificates, and he went on to prove that rubella during pregnancy could lead to deformities in b a b i e s . He also conducted important research
How
Do You
DETERMINE THE TRUTH?
31
into the effectiveness of antibiotics against tuberculosis, the disease that had ended his hopes of b e c o m i n g a doctor. T h e n , in 1948, Hill's interest turned towards lung cancer, because there had been a sixfold increase in cases of the disease in just t w o d e c a d e s . Experts were divided as to what was behind this health crisis, with s o m e of t h e m dismissing it as a consequence of better diagnosis, while others suggested that lung cancer w a s being triggered by industrial pollution, car fumes or perhaps smoking. With no consensus in sight, Hill teamed up with Doll and decided to investigate one of the proposed causes of lung cancer, namely smoking. H o w e v e r , they faced an obvious problem - they could not conduct a randomized clinical trial in this particular context. For instance, it would have been unethical, impractical and pointless to take 100 teenagers, persuade half of t h e m to s m o k e for a w e e k , and then look for signs of lung cancer. Instead, Hill and Doll decided that it would be necessary to devise a prospective cohort study or an observational study, which m e a n s that a group of healthy individuals is initially identified and then their subsequent health is monitored while they carry on their day-to-day lives. This is a much less interventionist approach than a randomized clinical trial, which is w h y a prospective cohort study is preferable for exploring long-term health issues. To spot any link between smoking and lung cancer in their prospective cohort study, Hill and Doll worked out that they would need to recruit volunteers w h o fulfilled three important criteria. First, the participants had to be established smokers or vehement nons m o k e r s , because this increased the likelihood that the pattern of behaviour of any individual would continue throughout the study, which would last several years. S e c o n d , the participants had to be reliable and dedicated, inasmuch as they would have to c o m m i t to the project and submit regular updates on their health and smoking habits during the course of the prospective cohort study. T h i r d , in order to control for other factors, it would help if all the participants were similar in terms of their b a c k g r o u n d s , income and w o r k i n g conditions. A l s o , the n u m b e r of participants had to be large, possibly several thousand, because this w o u l d lead to m o r e accurate conclusions.
32
TRICK OR TREATMENT?
Finding a group of participants that met these d e m a n d i n g requirements was not a trivial task, but Hill eventually thought of a solution while playing golf. This prompted his friend Dr W y n n e Griffith to c o m m e n t , T d o n ' t k n o w what kind of golfer he [is], but that was a stroke of g e n i u s . ' Hill's brilliant idea was to use doctors as his guinea pigs. Doctors fitted the bill perfectly: there were lots of t h e m , m a n y were heavy s m o k e r s , they were perfectly able to monitor their health and report back, and they were a relatively h o m o g e n o u s subset of the population. W h e n the smoking study c o m m e n c e d in 1 9 5 1 , the plan w a s to monitor more than 30,000 British doctors over the course of five d e c a d e s , but a clear pattern was already emerging by 1954. T h e r e had been thirty-seven deaths from lung cancer and every single o n e of t h e m was a smoker. As the data accumulated, the study implied that smoking increased the risk of lung cancer by a factor of twenty, and moreover it w a s linked to a range of other health p r o b l e m s , including heart attacks. T h e British Doctors Study, as it was k n o w n , w a s giving rise to such shocking results that some medical researchers were initially reluctant to accept the findings. Similarly, the cigarette industry questioned the research methodology, arguing that there must be a flaw in the way that the information was being gathered or analysed. Fortunately, British doctors were less sceptical about Hill and D o l l ' s emerging conclusions, because they themselves had been so involved in the study. H e n c e , they were not slow in advising the public against smoking. Because a link between cigarettes and lung c a n c e r would affect smokers around the world, it w a s important that the work of Hill and Doll w a s replicated and checked. T h e results of another study, this time involving 190,000 A m e r i c a n s , were also announced in 1954, and the conclusion painted a similarly stark picture. M e a n w h i l e , research with mice showed that half of them developed cancerous lesions w h e n their skin w a s coated in the tarry liquid extracted from tobacco s m o k e , showing that cigarettes definitely contained carcinogens. T h e picture was completed with more data from Hill and Doll's o n g o i n g fifty-year study - it reinforced in explicit detail the deadly effects of tobacco. F o r
How Do You DETERMINE THE TRUTH?
33
e x a m p l e , the analysis of British doctors showed that those born in the 1920s w h o s m o k e d were three times m o r e likely to die in their middle age than their n o n - s m o k i n g colleagues. M o r e specifically, 43 per cent of smokers compared to 15 per cent of non-smokers died between the ages of 35 and 69 years. Doll was as shocked as a n y o n e by the d a m n i n g evidence against smoking: T myself did not expect to find smoking was a major probl e m . If I ' d had to bet m o n e y at that t i m e , I would h a v e put it on something to do with the roads and m o t o r c a r s ' . Doll and Hill did not start their research in order to achieve a specific result, but instead they were merely curious and concerned about getting to the truth. M o r e generally, well-designed scientific studies and trials are not engineered to achieve an expected o u t c o m e , but rather they should be transparent and fair, and those conducting the research should be open to whatever results e m e r g e . The British Doctors Survey and similar studies were attacked by the tobacco industry, but Doll, Hill and their colleagues fought back and demonstrated that rigorous scientific research can establish the truth with such a level of authority that even the most powerful organizations cannot deny the facts for long. T h e link between smoking and lung cancer was proved beyond all reasonable doubt because of evidence emerging from several independent sources, each one confirming the results of the other. It is worth reiterating that progress in medicine requires independent replication - i.e. similar studies by more than one research group showing similar findings. Any conclusion that emerges from such a body of evidence is likely to be robust. Hill and Doll's research ultimately led to a raft of measures designed to persuade us not to s m o k e , which in turn has resulted in a 50 per cent decrease
in
smoking
in
many
parts
of the
developed
world.
Unfortunately, smoking still remains the single biggest cause of preventable deaths worldwide, because significant new markets are opening up in the developing world. Also, for many smokers the addiction is so great that they ignore or deny the scientific evidence. W h e n Hill and Doll first published their research in the British Medical Journal, an accompanying editorial recounted a very telling anecdote: 'It is said that the reader of an American magazine was so disturbed by an article
34
TRICK OR TREATMENT?
on the subject of smoking and cancer that he decided to give up reading.' While
we
were
writing this b o o k , the British Medical Journal
reminded the world of the contribution m a d e by Hill and Doll - it n a m e d the research that established the risks of smoking a m o n g a list of the fifteen greatest medical breakthroughs since the journal was launched 166 years a g o . Readers had been asked to vote for their favourite breakthrough in what seemed like the medical equivalent of Pop Idol. Although this high-profile popularity contest might have seemed vulgar to some a c a d e m i c s , it m a d e two important points, particularly in the context of this chapter. First, every breakthrough on the list illustrated the p o w e r of science to improve and save lives. For e x a m p l e , the list included oral rehydration, which helps recovery from diarrhoea and which has saved 50 million children's lives in the last twenty-five years. T h e list also included antibiotics, g e r m theory and i m m u n o l o g y , which together have helped to cure a whole range of diseases, thereby saving hundreds of millions of lives. Vaccines, of course, were on the list, because they have prevented many diseases from even occurring, thereby saving hundreds of millions more lives. And awareness of the risks of smoking has probably saved a similar n u m b e r of lives. T h e second point is that the concept of evidence-based medicine was also recognized a m o n g the top fifteen breakthroughs, because it too is a truly great medical achievement. As mentioned earlier, evidence-based medicine is simply about deciding best medical practice based on the best available e v i d e n c e . It lacks the glamour and glitz of some of the other shortlisted breakthroughs, but it is arguably the greatest one because it underpins so many of the others. For e x a m p l e , the k n o w l e d g e that vaccines and antibiotics are safe and protect against disease is only possible thanks to evidence gathered through clinical trials and other scientific investigations. Without evidencebased medicine, we risk falling into the trap of considering useless treatments as helpful, or helpful treatments as useless. Without evidence-based medicine we are likely to ignore the best treatments and instead rely on treatments that are m e d i o c r e , or poor, or useless, or even d a n g e r o u s , thereby increasing the suffering of patients. Even
before the principles of e v i d e n c e - b a s e d m e d i c i n e w e r e
How
Do You
DETERMINE THE TRUTH?
35
formalized, Lind, Hamilton, L o u i s , Nightingale, Hill and Doll, and hundreds of other medical researchers used the same approach to decide what works (lemons for scurvy), what does not work (bloodletting), what prevents disease (hygiene) and what triggers disease (smoking). T h e entire framework of modern medicine has emerged thanks to these medical researchers w h o used scientific methods such as clinical trials to gather evidence in order to get to the truth. N o w we can find out what happens when this approach is applied to alternative medicine. Alternative medicine claims to be able to treat the same illnesses and diseases that conventional medicine tries to tackle, and we can test these claims by evaluating the evidence. Any alternative treatment that turns out to be effective for a particular condition can then be c o m pared with conventional medicines to decide if the alternative should be used partially or wholly to replace the conventional. We are confident that we will be able to offer reliable conclusions about the value of the various alternative therapies, because many researchers have already been conducting trials and gathering evidence. In fact, there have been thousands of clinical trials to determine the efficacy of alternative therapies. S o m e of them have been conducted with great rigour on large populations of patients and then independently replicated, so the overall conclusions can be relied upon. The remaining chapters of this book are devoted to analysing the results of these trials across a whole range of alternative therapies. O u r goal is to e x a m ine the evidence and then tell you which therapies work and which ones fail, which ones are safe and which ones are dangerous. At this early stage of the b o o k , m a n y alternative therapists might feel optimistic that their particular therapy will emerge triumphant when we analyse the data concerning its efficacy. After all, these alternative therapists can probably identify with the mavericks that have populated this chapter. Florence Nightingale would have been perceived as a maverick during her early career, because she was prioritizing hygiene when everybody else involved in healthcare was focused on other things, such as surgery and pills. But she proved that she was right and that the establishment was w r o n g .
36
TRICK OR TREATMENT?
James Lind was also a maverick w h o turned out to be right, because he showed that lemons were effective for scurvy when the medical establishment w a s promoting all sorts of other remedies. Alexander Hamilton was another maverick w h o knew more than the establishment, because he argued against bloodletting in an era when bleeding w a s a standard procedure. A n d Hill and Doll were m a v e r i c k s , because they showed that smoking was a surprisingly deadly indulgence, and moreover they produced data that stood up against the powerful interests of the cigarette industry. Such heroic mavericks pepper the history of medicine and they also act as powerful role m o d e l s for modern m a v e r i c k s , including alternative therapists. Acupuncturists, h o m e o p a t h s and other practitioners rail against the establishment with theories and therapies that run counter to our current understanding of medicine, and they loudly proclaim that the e s t a b l i s h m e n t d o e s not
understand t h e m . T h e s e
therapists predict that, one day, the establishment will acknowledge their apparently strange ideas. T h e y believe that they will earn their o w n rightful place in the history b o o k s , alongside Nightingale, Lind, Hamilton, Hill and Doll. Unfortunately, these alternative therapists ought to realize that only a minority of mavericks ever turn out to be on the right track. Most mavericks are simply deluded and w r o n g . Alternative therapists might be excited by a line from George Bernard S h a w ' s play Annajanska, the Bolshevik Empress, in which the Grand Duchess points out: 'All great truths begin as blasphemies.' However, they might be less encouraged by the caveat that should a c c o m p a n y this line: ' N o t all blasphemies b e c o m e great truths.' Perhaps one of the best reasons to categorize a medical treatment as alternative is if the establishment views it as b l a s p h e m o u s . In this context, the aim of our book is to evaluate the scientific evidence that relates to each alternative treatment to see if it is a blasphemy on the path to revolutionizing medicine or if it is a blasphemy that is destined to remain in the cul-de-sac of crazy ideas.
How
Do You
DETERMINE THE TRUTH?
37
The Truth About Acupuncture 'There must be something to acupuncture - you never see any sick porcupines.' Bob Goddard
Acupuncture An ancient system of medicine based on the notion that health and wellbeing relate to the flow of a life force (Ch'i) through pathways (meridians) in the human body. Acupuncturists place fine needles into the skin at critical points along the meridians to remove blockages and encourage a balanced flow of the life force. They claim to be able to treat a wide range of diseases and symptoms.
M O S T PEOPLE A S S U M E THAT ACUPUNCTURE, THE PROCESS OF PUNCTURING
the skin with needles to improve health, is a system of medicine that has its origins in C h i n a . In fact, the oldest evidence for this practice has been discovered in the heart of E u r o p e . In 1991 two G e r m a n tourists, Helmut and Erika S i m o n , w e r e hiking across an alpine glacier in the Otz valley near the border between Italy and Austria w h e n they encountered a frozen corpse. At first they assumed it was the body of a modern hiker, many of w h o m have lost their lives due to treacherous weather conditions. In fact, they had stumbled upon the remains of a 5,000-year-old m a n . Otzi the I c e m a n , n a m e d after the valley in which he was found, b e c a m e world famous because his b o d y had been remarkably well preserved b y the i n t e n s e c o l d , m a k i n g h i m the oldest E u r o p e a n mummified h u m a n by far. Scientists began examining Otzi, and soon a startling series of discoveries e m e r g e d . T h e contents of his stomach, for instance, revealed that he had chamois and red-deer meat for his final meals. A n d , by examining pollen grains mixed in with the meat, it was possible to show that he had died in the spring. He carried with him an axe m a d e of 99.7 per cent pure copper, and his hair showed high levels of copper contamination, implying that he may have smelted copper for a living. O n e of the more unexpected avenues of research w a s initiated by Dr Frank
B a h r from
the
German Academy
for A c u p u n c t u r e
and
Auriculomedicine. For h i m , the most interesting aspect of Otzi was a series of tattoos that covered parts of his body. These tattoos consisted of lines and dots, as opposed to being pictorial, and seemed to form fifteen distinct groups. Moreover, Bahr noticed that the markings were in familiar positions: T was amazed - 80 per cent of the points correspond to those used in acupuncture today.' W h e n he showed the images to other acupuncture experts, they
T H E TRUTH A B O U T ACUPUNCTURE
41
agreed that the majority of tattoos seemed to lie within 6 m m of k n o w n acupuncture points, and that the remainder all lay close to other areas of special significance to acupuncture. Allowing for the distortion of Otzi's skin in the past 5,000 years, it was even possible that every single tattoo corresponded with an acupuncture point. Bahr c a m e to the conclusion that the markings were m a d e by an ancient healer in order to allow Otzi to treat himself by using the tattoos as a guide for applying needles to the correct sites. Whilst critics have suggested that the overlap between the tattoos and acupuncture points is nothing more than a meaningless coincidence, Bahr remains confident that Otzi was indeed a prehistoric acupuncture patient. He points out that the pattern of tattoos indicates a particular acupuncture therapy - the majority of tattoo sites are exactly those that would be used by a modern acupuncturist to treat back pain, and the remainder can be linked to abdominal disorders. In a paper published in 1999 in the highly respected journal Lancet, Bahr and his colleagues wrote: ' F r o m an acupuncturist's viewpoint, the combination of points selected represents a meaningful therapeutic regimen.' Not only do we have an apparent treatment r e g i m e , but we also have a diagnosis that fits the speculation, because radiological studies have shown that Otzi suffered from arthritis in the lumbar region of his spine, and we also k n o w that there were n u m e r o u s whipw o r m eggs in his colon that would have caused him serious abdominal problems. Despite claims that Otzi is the world's earliest k n o w n acupuncture patient, the Chinese insist that the practice originated in the Far East. According to legend, the effects of acupuncture were serendipitously discovered when a soldier fighting in the Mongolian War in 2,600 BC was struck by an arrow. Fortunately it was not a lethal shot, and even more fortunately it supposedly cured him of a longstanding illness. More concrete evidence for the origins of acupuncture has been found
in
discovered
prehistoric fine
stone
burial tools
tombs, where apparently
archaeologists
intended
have
for n e e d l i n g .
O n e line of speculation is that such tools were fashioned because of the ancient Chinese belief that all disease was caused by d e m o n s within the h u m a n body. It m a y have been thought that the insertion
42
TRICK OR TREATMENT?
of needles into the body could kill or release such d e m o n s . T h e first detailed description of acupuncture appears in the Huangdi Neijing
(known
as
the
The
Yellow
Emperor's
Classic
of Internal
Medicine), a collection of writings dating from the second century B C . It presents the complex philosophy and practice of acupuncture in terms that would be largely familiar to any m o d e r n practitioner. M o s t importantly of all, Huangdi Neijing describes h o w Ch'i, a vital energy or life force, flows though our b o d y via channels k n o w n as meridians. Illnesses are due to imbalances or blockages in the flow of C h ' i , a n d the goal of acupuncture is to tap into the meridians at key points to rebalance or unblock the C h ' i . Although Ch'i
is a c o r e p r i n c i p l e in a c u p u n c t u r e , different
schools have evolved over the centuries and developed their o w n interpretations
of how
Ch'i
flows through the body. F o r instance, s o m e acupuncturists work on the basis of fourteen main meridians carrying C h ' i , while the
the
majority
notion
contains
that
only
support
the
body
twelve
main
m e r i d i a n s . Similarly, different schools of acupuncture included
additional
have
concepts,
such as yin a n d y a n g , a n d interpreted ways. divided three
them
While yin
in
different
some
schools
and
yang
subcategories,
divided
them
into
others
into
four.
B e c a u s e t h e r e are s o m a n y schools is
of
acupuncture,
impractical
to
give
it a
detailed description of each of Acupuncture chart from the Ming dynasty, showing the meridians, or channels, through which our Ch 'i is said to flow.
t h e m , but these are the core principles:
THE TRUTH A B O U T ACUPUNCTURE
43
•
Each meridian is associated with and connects to one of the major organs.
•
Each meridian has an internal and an external pathway. Although the internal p a t h w a y s are buried deep within the body, the external ones are relatively near the surface and are accessible to needling.
• There are hundreds of possible acupuncture points along the meridians. •
D e p e n d i n g on the school and the condition being treated, the acupuncturist will insert needles at particular points on particular meridians.
•
The penetration depth varies from 1 centimetre to over 10 centimetres, and often the therapy involves rotating the needles in situ.
•
Needles can be left in place for a few seconds or a few h o u r s . Before deciding on the acupuncture points, as well as the duration,
depth and m o d e of needling, the acupuncturist must first diagnose the patient.
This
auscultation,
relies
olfaction,
on
five
palpation
techniques,
and
namely
inquiring.
Inspection
inspection, means
examining the body and face, including the colour and coating of the tongue. Auscultation and olfaction entail listening to and smelling the body, checking for s y m p t o m s such as wheezing and unusual odours. Palpation involves checking the patient's pulse: importantly, acupuncturists claim to be able to discern far more information from this process than any conventional doctor. Inquiring, as the n a m e suggests, m e a n s simply interviewing the patient. Claims by the Chinese that acupuncture could successfully diagnose and miraculously cure a whole range of diseases inevitably aroused interest from the rest of the world. T h e first detailed description by a European physician was by Wilhelm ten R h y n e of the Dutch East India C o m p a n y in 1683, w h o invented the word acupuncture in his Latin treatise
De Acupunctura.
A few
years
later,
a
German
traveller
and doctor named Engelbert Kaempfer brought back reports of acupuncture from J a p a n , where it w a s not restricted to specialist practitioners: ' E v e n the c o m m o n people will venture to apply the needle merely upon their o w n experience . . . taking care only not to prick any nerves, t e n d o n s , or considerable blood vessels.'
44
TRICK OR TREATMENT?
In t i m e , some European doctors began to practise acupuncture, but they tended to reinterpret the underlying principles to fit in with the latest scientific discoveries. For e x a m p l e , in the early nineteenth century Louis Berlioz, father of the famous composer, found acupuncture to be beneficial for relieving muscular pain and nervous conditions. He speculated that the healing m e c h a n i s m might be linked to the findings of Luigi Galvani, w h o had discovered that electrical impulses could cause a dissected frog's leg to twitch. Berlioz suggested that acupuncture needles might be interrupting or enabling the flow of electricity within the body, thereby replacing the abstract notions of C h ' i and meridians with the more tangible concepts of electricity and nerves. This led to Berlioz's proposal that the effects of acupuncture might be enhanced by connecting the needles to a battery. At the same time, acupuncture was also growing in popularity in America, which prompted some physicians to conduct tests into its efficacy. For example, in 1826 there was an attempt in Philadelphia to resuscitate drowned kittens by inserting needles into their hearts, an experiment
Figure 1 A patient receiving acupuncture at several points on the face. Three yang meridians are said to begin in the facial region.
THE TRUTH A B O U T ACUPUNCTURE
45
based on the claims of European acupuncturists. Unfortunately the American doctors had no success and 'gave up in disgust'. M e a n w h i l e , European acupuncturists continued to publish articles reporting positive results, such as one that appeared in the Lancet in 1836 describing h o w acupuncture had been used to cure a swelling of the scrotum. At the same t i m e , the therapy b e c a m e particularly popular in high society thanks to its promotion by figures such as George O ' B r i e n , 3rd Earl of E g r e m o n t , w h o was cured of sciatica. He was so impressed that he renamed his favourite racehorse Acupuncture as an act of gratitude towards the w o n d r o u s therapy. Then, from around 1840, just when it seemed that acupuncture was going to establish itself within mainstream Western medicine, the wealthy elite adopted new medical fads and the number of acupuncturists dwindled. European rejection of the practice was mainly linked to disputes such as the First and Second O p i u m Wars between Britain and China, which led to a contempt for China and its traditions - acupuncture was no longer perceived as a potent therapy from the mysterious East, but instead it was considered a sinister ritual from the evil Orient. Meanwhile, acupuncture was also in decline back in China. The Daoguang Emperor (1782-1850) felt it was a barrier to medical progress and removed it from the curriculum of the Imperial Medical Institute. By the start of the twentieth century, acupuncture was extinct in the West and dormant in the East. It might have fallen out of favour permanently, but it suddenly experienced a revival in 1949 as a direct result of the communist revolution and the establishment of the People's Republic of China. Chairman M a o Tse-tung engineered a resurgence in traditional Chinese medicine, which included not just acupuncture, but also Chinese herbal medicine and other therapies. His motivation was partly ideological, inasmuch as he wanted to reinforce a sense of national pride in Chinese medicine. However, he was also driven by necessity. He had promised to deliver affordable healthcare in both urban and rural regions, which was only achievable via the network of traditional healers, the so-called 'barefoot doctors'. M a o did not care whether traditional Chinese medicine worked, as long as he could keep the masses contented. In fact, his personal physician, Zhisui Li, wrote a memoir entitled The Private Life of Chairman Mao, in which he quoted M a o as saying, 'Even
46
TRICK OR TREATMENT?
though I believe we should promote Chinese medicine, I personally do not believe in it. I don't take Chinese medicine.' Because of C h i n a ' s isolation, its renewed interest in acupuncture went largely unnoticed in the West - a situation which changed only w h e n plans were being m a d e for President N i x o n ' s historic trip to China in 1972. This was the first time that an A m e r i c a n President had visited the People's Republic of C h i n a , so it was preceded by a preparatory visit by Henry Kissinger in July 1971. Even Kissinger's visit was a major event, so he was accompanied by a cohort of journalists, which included a reporter called J a m e s Reston. Unfortunately for Reston, soon after arriving in C h i n a he was struck by a stabbing pain in his groin. He later recalled h o w his condition deteriorated during the day: ' B y evening I had a temperature of 103 degrees and in my delirium I could see Mr. Kissinger floating across my b e d r o o m ceiling grinning at me out of the corner of a hooded rickshaw.' It soon became obvious that he had appendicitis, so Reston was urgently admitted to the Anti-Imperialist Hospital for a standard surgical procedure. The operation went smoothly, but two nights later Reston began to suffer severe abdominal pains which were treated with acupuncture. He was cared for by Dr Li C h a n g - y u a n , w h o had not been to medical college, but w h o instead had served an apprenticeship with a veteran acupuncturist. He told Reston that he had learned much of his craft by practising on himself: 'It is better to w o u n d yourself a thousand times than to do a single harm to another person.' James Reston found the treatment to be both shocking and effective in equal measure, and he wrote up his experience in an article published in the New York Times on 26 July 1971. Under the headline M Y O P E R A T I O N IN P E K I N G ' ,
' N O W ABOUT
Reston described how the acupuncturist had
inserted needles into his right elbow and just below both knees. Americans must have been amazed to read h o w the needles were then 'manipulated in order to stimulate the intestine and relieve the pressure and distension of the s t o m a c h ' . Reston praised the way that this traditional technique had eased his pain, which resulted in the article generating e n o r m o u s interest a m o n g medical experts. Indeed, it was not long before White House physicians and other American doctors were visiting China to see the p o w e r of acupuncture with their o w n eyes.
THE TRUTH A B O U T ACUPUNCTURE
47
During the early 1970s, these observers witnessed truly staggering e x a m p l e s of Chinese acupuncture. Perhaps the most impressive demonstration was the use of acupuncture during major surgery. A certain Dr Isadore Rosenfeld, for instance, visited the hospital at the University of S h a n g h a i twenty-eight-year-old
female
and reported on the c a s e of a
patient
who
underwent
open-heart
surgery to repair her mitral valve. Astonishingly, the surgeons used acupuncture to her left earlobe in place of the usual anaesthetics. T h e surgeon cut through the breastbone with an electric buzzsaw and opened her chest to reveal her heart. Dr Rosenfeld described how she remained a w a k e and alert throughout: ' S h e never flinched. There was no m a s k on her face, no intravenous needle in her arm . . . I took a color photograph of that m e m o r a b l e scene: the open chest, the smiling patient, and the surgeon's hands holding her heart. I show it to anyone w h o scoffs at a c u p u n c t u r e . ' Such extraordinary cases, documented by reputable doctors, had an immediate effect back in America. Physicians were clamouring to attend the three-day crash courses in acupuncture that were running in both America and China, and increasing numbers of acupuncture needles were being imported into America. At the same time, American legislators were deciding what to m a k e of this newfound medical marvel, because there had been no formal assessment of whether or not acupuncture really worked. Similarly there had been no investigation into the safety of acupuncture implements, which was why the Food and Drug Administration ( F D A ) attempted to prevent shipments of needles from entering the United States. Eventually the F D A softened its position and accepted the importation of acupuncture needles under the label of experimental devices. The Governor of California, Ronald Reagan, took a similar line, and in August 1972 he signed into law a bill that permitted acupuncture, but only in approved medical schools and only so that scientists might test its safety and efficacy. In hindsight, we can see that those w h o argued for caution were probably correct. It now seems highly likely that m a n y of the Chinese demonstrations involving surgery had been faked, inasmuch as the acupuncture was being supplemented by local anaesthetics, sedatives or other means of pain control. Indeed, it is a deception that has occurred
48
TRICK OR TREATMENT?
as recently as 2 0 0 6 , when the B B C TV series Alternative Medicine generated national interest after showing an operation that was almost identical to the one observed by Dr Rosenfeld three decades earlier. Again, acupuncture was being used on a female patient in her twenties, also undergoing open-heart surgery, and also in Shanghai. T h e B B C ' s presenter explained that: ' S h e ' s still c o n s c i o u s , because instead of a general anaesthetic this twenty-first-century surgical t e a m are using a two-thousand-year-old m e t h o d of controlling pain acupuncture.' British journalists and the general public were a m a z e d by the extraordinary i m a g e s , but a report by the Royal College of Anaesthetists cast the operation in a different light: It is obvious, from her appearance, that the patient has already received sedative drugs and I am informed that these comprised midazolam, droperidol and fentanyl. The doses used were small, but these types of drugs 'amplify' the effect of each other so that the effect becomes greater. Fentanyl is not actually a sedative drug in the strict sense, but it is a pain-killing drug that is considerably more powerful than morphine. The third component of the anaesthetic is seen on the tape as well, and that is the infiltration of quite large volumes of local anaesthetic into the tissues on the front of the chest where the surgical incision is made. In short, the patient had received sufficiently large d o s e s of conventional drugs to mean that the acupuncture needles w e r e a red herring, probably playing nothing m o r e than a cosmetic or p s y c h o logical role. The American physicians w h o visited China in the early 1970s were not accustomed to deception or political manipulation, so it took a couple of years before their naive zeal for acupuncture turned to doubt. Eventually, by the mid- 1970s, it had b e c o m e clear to many of them that the use of acupuncture as a surgical anaesthetic in China had to be treated with scepticism. Films of impressive medical procedures made by the Shanghai Film Studio, which had once been shown in American medical schools, were reinterpreted as propaganda. M e a n w h i l e , the Chinese authorities continued to make outrageous claims for acupuncture, publishing brochures that contained assertions such as: ' D e e p
THE TRUTH A B O U T ACUPUNCTURE
49
needling of the yamen point enables deaf-mutes to hear and speak . . . And w h e n the devil w a s cast out, the d u m b spake: and the multitudes marvelled.' A c u p u n c t u r e ' s reputation in the West had risen and fallen in less than a d e c a d e . It had been praised unreservedly following President N i x o n ' s visit to C h i n a , only later to be treated with suspicion by the medical establishment. This did not m e a n , however, that Western physicians were necessarily close-minded to the w h o l e notion of acupuncture. T h e m o r e extraordinary claims might have been unjustified, but perhaps m a n y of the other supposed benefits were genuine. T h e only w a y to find out would be for acupuncture to pass through the same protocols that would be required of any new treatment. T h e situation was best summarized by the A m e r i c a n Society of Anesthesiologists, w h o issued a statement in 1973 that highlighted the need for caution, while also offering a way forward:
The safety of American medicine has been built on the scientific evaluation of each technique before it becomes a widely accepted concept in medical practice. The premature use of acupuncture in the United States at this time departs from this traditional approach. A potentially valuable technique which has been developed over thousands of years in China is being hastily applied with little thought to safeguards or hazards. Among the potential hazards is the application to the patient who has not been properly evaluated psychologically. If acupuncture is applied indiscriminately, severe mental trauma could result in certain patients. Another hazard is the possible misuse by quacks in attempting to treat a variety of illnesses, including cancer and arthritis, thus diverting the patient from obtaining established medical therapy. Exploitation may delude the public into believing that acupuncture is good for whatever ails you. Acupuncture may indeed have considerable merit and may eventually find an important role in American medicine. That role can only be determined by objective evaluation over a period of years.
T h e American Society of Anesthesiologists, therefore, w a s neither accepting nor rejecting the use of acupuncture, but instead it was simply arguing for rigorous testing. These level-headed experts were not
50
TRICK OR TREATMENT?
interested in anecdotes, but rather they wanted 'objective evaluation' with large numbers of patients. In other words, they wanted to see acupuncture submitted to the sort of clinical trials discussed in Chapter 1, which had decided the effectiveness of treatments such as bloodletting and lemon juice for scurvy. Perhaps acupuncture would turn out to be as useless as bloodletting, or perhaps it would be as effective as lemons. There was only one way to find out: do proper research. During the 1970s universities and hospitals across America began submitting acupuncture to clinical trials, all part of a massive effort to test its impact on a variety of ailments. S o m e of the trials involved just a handful of patients, whereas others involved d o z e n s . S o m e tracked the impact of acupuncture in the hours immediately following a o n e off treatment, while others looked at long-term treatments and monitored the progress of patients over several w e e k s or even m o n t h s . T h e diseases studied ranged from lower back pain to angina, from migraine to arthritis. Despite the wide variety of clinical trials, they broadly followed the principles that had been laid d o w n by J a m e s Lind: take patients with a particular condition, randomly assign t h e m either to an acupuncture group or to a control g r o u p , and see if those receiving acupuncture improve more than the control group. A huge n u m b e r of trials had been conducted by the end of the d e c a d e , so in
1979 the World Health Organization Inter-regional
Seminar asked R. H. Bannerman to summarize the evidence for and against acupuncture. His conclusions shocked sceptics and vindicated the C h i n e s e . In Acupuncture: the WHO view, B a n n e r m a n stated that there were more than twenty conditions which 'lend themselves to acupuncture t r e a t m e n t ' , including sinusitis, c o m m o n cold, tonsillitis, bronchitis, asthma, duodenal ulcers, dysentery, constipation, diarrhoea, headache and migraine, frozen shoulder, tennis elbow, sciatica, low back pain and osteoarthritis. This W H O d o c u m e n t , and other similarly positive c o m m e n t a r i e s , marked a watershed in terms of acupuncture's credibility in the West. Budding practitioners could n o w sign up to courses with confidence, safe in the knowledge that this w a s a therapy that genuinely w o r k e d . Similarly, the n u m b e r of patients waiting for treatment began to rise rapidly, as they became increasingly convinced of the p o w e r of
THE TRUTH A B O U T ACUPUNCTURE
51
acupuncture. For e x a m p l e , by 1990 in E u r o p e alone there w e r e 88,000 acupuncturists and over 20 million patients had received treatment. M a n y acupuncturists were independent practitioners, but slowly the therapy w a s also b e c o m i n g part of m a i n s t r e a m m e d i c i n e . T h i s w a s highlighted by a British Medical Association survey in 2 0 0 2 , which revealed that roughly half of all practising doctors h a d arranged acupuncture sessions for their patients. T h e only remaining mystery seemed to be the m e c h a n i s m that was making acupuncture so effective. A l t h o u g h Western doctors w e r e n o w b e c o m i n g sympathetic to the notion that needling specific points on the b o d y could lead to apparently dramatic c h a n g e s in a p e r s o n ' s health, they were highly sceptical about the existence of meridians or the flow of C h ' i . T h e s e concepts h a v e no m e a n i n g in t e r m s of biology, chemistry or p h y s i c s , but rather they are based on ancient tradition. T h e contrast between Western incredulity and Eastern confidence in C h ' i and meridians can be traced back to the evolution of the t w o medical traditions, particularly the w a y in w h i c h the subject of anatomy w a s treated in the t w o h e m i s p h e r e s . Chinese medicine e m e r g e d from a society that rejected h u m a n dissection. Unable to look inside the body, the C h i n e s e d e v e l o p e d a largely imaginary model of h u m a n anatomy that w a s based on the world around t h e m . For e x a m p l e , the h u m a n b o d y w a s supposed to have 365 distinct c o m p o n e n t s , but only because there are 365 days in the year. Similarly, it seems likely that the belief in twelve meridians emerged as a parallel to the twelve great rivers of C h i n a . In short, the h u m a n body was interpreted as a m i c r o c o s m of the u n i v e r s e , as opposed to understanding it in terms of its o w n reality. T h e Ancient G r e e k s also had reservations about using corpses for medical research, but m a n y notable physicians w e r e prepared to break with tradition in order to study the h u m a n body. F o r instance, in the third century B C , Herophilus of Alexandria explored the brain and its connection to the nervous system. He also identified the ovaries and the fallopian tubes, and w a s credited with disproving the bizarre and widely held view that the w o m b wandered around the female body. In contrast to the C h i n e s e , European scientists gradually d e v e l o p e d an acceptance that dissecting the h u m a n b o d y w a s a necessary part of
52
TRICK OR TREATMENT?
medical research, so there w a s steady progress towards establishing an accurate picture of our anatomy. Autopsies w e r e b e c o m i n g c o m m o n by the thirteenth century, and public dissections for the p u r p o s e of teaching anatomy w e r e taking place across E u r o p e by the e n d of the fourteenth century. By the midsixteenth century, the practice of dissection for teaching a n a t o m y to medical students had b e c o m e standard, largely thanks to the influence of such leading figures as Vesalius, w h o is a c k n o w l e d g e d to be the founder of m o d e r n anatomy. He argued that a doctor could not treat the h u m a n b o d y unless he u n d e r s t o o d its construction, but unfortunately obtaining bodies w a s still a p r o b l e m . This forced Vesalius, in 1536, to steal the b o d y of an executed criminal still chained to the gibbet. His aim w a s to obtain a skeleton for research. Luckily m u c h of the flesh had already rotted a w a y or had b e e n eaten by a n i m a l s , so m u c h so that the bones w e r e 'held together by the ligaments a l o n e ' . In 1543 he p u b lished his masterpiece, De the
Human
Corporis Fabrica or The Construction of
Body.
Early E u r o p e a n anatomists realized that even the most elementary discoveries about the h u m a n b o d y could lead to profound revelations about h o w it functions. F o r instance, in the sixteenth century an anatomist n a m e d H i e r o n y m u s Fabricus discovered that veins contain one-way valves along their length, which implies that blood flows in only one direction. William H a r v e y used this information to argue in favour of blood circulating around the body, which in turn ultimately led to a clear understanding of h o w o x y g e n , nutrients and disease spread through the h u m a n body. Today, modern medicine continues to d e v e l o p by ever-closer e x a m i n a t i o n of h u m a n anatomy, with increasingly powerful m i c r o s c o p e s for seeing and with ever finer instruments for dissecting. M o r e o v e r , today we can gain insights into a living d y n a m i c body, thanks to e n d o s c o p e s , X - r a y s , M R I scans, CAT scans and ultrasound - and yet scientists are still unable to find a shred of evidence to support the existence of meridians or C h ' i . S o , if meridians and C h ' i are fictional, then what is the m e c h a n i s m behind the apparent healing p o w e r of acupuncture? T w o decades after N i x o n ' s visit to C h i n a h a d re-introduced acupuncture to the West, scientists had to admit that they w e r e baffled over h o w acupuncture
T H E TRUTH A B O U T ACUPUNCTURE
53
could supposedly treat so m a n y ailments, ranging from sinusitis to gingivitis, from impotence to dysentery. H o w e v e r , w h e n it c a m e to pain relief, there were tentative theories that seemed credible. T h e first theory, k n o w n as the gate control theory of pain, w a s developed in the early 1960s, a decade before scientists w e r e thinking about acupuncture. A Canadian n a m e d Ronald M e l z a c k and an E n g l i s h m a n n a m e d Patrick Wall jointly suggested that certain nerve fibres, which conduct impulses from the skin to m o r e central j u n c t i o n s , also have the ability to close a so-called ' g a t e ' . If the gate is closed, then other impulses, perhaps associated with pain, struggle to reach the brain and are less likely to be recognized as pain. T h u s relatively minor stimuli might suppress major pain from other sources by shutting the gate before the troubling pain impulse can reach the brain. T h e gate control theory of pain has b e c o m e widely accepted as an explanation of why, for e x a m p l e , rubbing a painful limb is soothing. Could gate control, however, explain the effects of acupuncture? M a n y a c u p u n c turists in the West argued that the sensation caused by an acupuncture needle was capable of shutting gates and blocking major pain, but sceptics pointed out that there was no solid evidence to show that this was the c a s e . T h e gate control theory of pain was valid in other situations, but acupuncture's ability to exploit it was u n p r o v e n . T h e second theory for explaining the p o w e r of acupuncture is based on the existence of chemicals called opioids, which act as powerful, natural painkillers. The most important opioids are known as endorphins. Some studies have indeed shown that acupuncture somehow stimulates the
release
of these
chemicals
in
the
brain.
Not
surprisingly,
acupuncturists have welcomed these studies, but again there have been sceptics. They question whether acupuncture can release enough opioids to create any significant pain relief, and they cite other studies that fail to confirm any connection between endorphins and acupuncture. In short, here were two theories that could potentially explain the powers of acupuncture, but as yet they were both too tentative to convince the medical establishment. So instead of accepting either theory, scientists urged further research. Meanwhile, they also began to propose a separate explanation to account for the pain relief provided by acupuncture. In fact, if correct, this third theory could potentially explain all its
54
TRICK O R TREATMENT?
supposed benefits, not just pain relief. Unfortunately for acupuncturists, this third theory attributed the impacts of acupuncture to the placebo effect, a medical phenomenon with a long and controversial history. In one sense, any form of treatment that relies heavily on the placebo effect is fraudulent. Indeed, many bogus therapies from the nineteenth century had turned out to be nothing more than placebo-based treatments. In the next section we will explore the placebo effect in detail and see how it might relate to acupuncture. If the placebo effect can successfully explain the apparent benefits of acupuncture, then 2,000 years of Chinese medical expertise would evaporate. If not, then the medical establishment would be forced to take acupuncture seriously.
The power of placebo T h e first medical patent issued under the Constitution of the United States was awarded in 1796 to a physician named Elisha Perkins, w h o had invented a pair of metal rods which he claimed could extract pains from patients. These tractors, as he dubbed them, were not inserted into the patient, but were merely brushed over the painful area for several minutes, during which time they would ' d r a w off the noxious electrical fluid that lay at the root of suffering'. Luigi Galvani had recently shown that the nerves of living organisms responded to 'animal electricity', so P e r k i n s ' tractors were part of a g r o w i n g fad for healthcare based on the principles of electricity. As well as providing electrotherapeutic cures for all sorts of pains, Perkins claimed that his tractors could also deal with r h e u m a t i s m , gout, n u m b n e s s and muscle w e a k n e s s . He soon boasted of 5,000 satisfied patients and his reputation was buoyed by the support of several medical schools and high-profile figures such as George Washington, w h o had himself invested in a pair of tractors. T h e idea was then exported to E u r o p e when P e r k i n s ' son, Benjamin, emigrated to L o n d o n , where he published The Influence of Metallic Tractors on the Human Body. Both father and son m a d e fortunes from their devices - as well as charging their o w n patients high fees for tractor therapy sessions, they also sold tractors to other physicians for the cost of 5 guineas each. T h e y claimed that the tractors were so expensive
T H E TRUTH A B O U T ACUPUNCTURE
55
because they were m a d e of an exotic metal alloy, and this alloy was supposedly crucial to their healing ability. H o w e v e r , John H a y g a r t h , a retired British physician, b e c a m e suspicious about the miraculous powers of the tractors. He lived in Bath, then a popular health resort for the aristocracy, and he was continually hearing about cures attributed to Perkins' tractors, which were all the rage. He accepted that patients treated with P e r k i n s ' tractors w e r e indeed feeling better, but he speculated that the d e v i c e s w e r e essentially fake and that their impact was on the m i n d , not the body. In other w o r d s , credulous patients might be merely convincing themselves that they felt better, because they had faith in the m u c h - h y p e d and expensive P e r k i n s ' tractors. In order to test his theory he m a d e a suggestion in a letter to a colleague: Let their merit be impartially investigated, in order to support their fame, if it be well-founded, or to correct the public opinion, if merely formed upon delusion . . . Prepare a pair of false Tractors, exactly to resemble the true Tractors. Let the secret be kept inviolable, not only from the patient but also from any other person. Let the efficacy of both be impartially tried and the reports of the effects produced by the true and false Tractors be fully given in the words of the patients. Haygarth was suggesting that patients be treated with tractors m a d e from Perkins' special alloy and with fake tractors m a d e of ordinary materials to see if there was any difference in o u t c o m e . T h e results of the trial, which w a s conducted in
1799 at B a t h ' s Mineral Water
Hospital and Bristol Infirmary, were exactly as Haygarth had suspected - patients reported precisely the same benefits whether they were being treated with real or fake tractors. S o m e of the fake, yet effective, tractors w e r e m a d e of b o n e , slate and even painted tobacco pipes. None of these materials could conduct electricity, so the entire basis of P e r k i n s ' tractors was undermined. Instead Haygarth proposed a new explanation for their apparent effectiveness, namely that ' p o w erful influences upon diseases is produced by mere i m a g i n a t i o n ' . Haygarth argued that if a doctor could persuade a patient that a treatm e n t w o u l d w o r k , then this p e r s u a s i o n alone c o u l d c a u s e a n
56
TRICK OR TREATMENT?
improvement in the patient's condition - or it could at least convince the patient that there had been such an improvement. In one particular case, Haygarth used tractors to treat a w o m a n with a locked elbow joint. Afterwards she claimed that her mobility had increased. In fact, close observation showed that the elbow was still locked and that the lady was compensating by increasing the twisting of her shoulder and wrist. In 1800 Haygarth published Of the Imagination as a Cause and as a Cure of Disorders of the Body, in which he argued that P e r k i n s ' tractors were no more than quackery and that any benefit to the patient was psychological - medicine had started its investigation into what we today would call the placebo effect. T h e word placebo is Latin for 'I will p l e a s e ' , and it was used by writers such as Chaucer to describe insincere expressions that nevertheless can be consoling: 'Flatterers are the devil's chaplains that continually sing placebo.' It was not until 1832 that placebo took on its specific medical m e a n i n g , namely an insincere or ineffective treatment that can nevertheless be consoling. Importantly, Haygarth realized that the p l a c e b o effect is not restricted to entirely fake treatments, and he argued that it also has a role to play in the impact of genuine medicines. For e x a m p l e , although a patient will derive benefit from taking aspirin largely due to the pill's biochemical effects, there can also be an added bonus benefit due to the placebo effect, which is a result of the patient's confidence in the aspirin itself or confidence in the physician w h o prescribes it. In other w o r d s , a genuine medicine offers a benefit that is largely due to the medicine itself and partly due to the placebo effect, whereas a fake medicine offers a benefit that is entirely due to the placebo effect. As the placebo effect arises out of the patient's confidence in the treatment, Haygarth wondered about the factors that would increase that confidence and thereby maximize the p o w e r of the placebo. He concluded that, a m o n g other things, the d o c t o r ' s reputation, the cost of the treatment and its novelty could all boost the placebo effect. M a n y physicians
throughout
history
have
been
quick
to
hype
their
reputations, link high cost with medical potency and emphasize the novelty of their cures, so perhaps they were already aware of the placebo effect. In fact, prior to Haygarth's e x p e r i m e n t s , it seems
THE TRUTH A B O U T ACUPUNCTURE
57
certain that doctors had been secretly exploiting it for centuries. Nevertheless, Haygarth deserves credit for being the first to write about the placebo effect and bringing it out into the o p e n . Interest in the placebo effect grew over the course of the nineteenth century, but it w a s only in the 1940s that an A m e r i c a n anaesthetist n a m e d Henry Beecher established a rigorous p r o g r a m m e of research into its potential. B e e c h e r ' s o w n interest in the placebo effect w a s aroused towards the end of the Second World War, w h e n a lack of morphine at a military field hospital forced him to try an extraordinary experiment. Rather than treating a w o u n d e d soldier without m o r p h i n e , he injected saline into the patient and suggested to the soldier that he w a s receiving a powerful painkiller. To B e e c h e r ' s surprise, the patient relaxed immediately and showed no signs of pain, distress or shock. Moreover, when morphine supplies ran low again, the sly doctor disc o v e r e d that he c o u l d
repeatedly
play
this
trick on
patients.
Extraordinarily, it seemed that the placebo effect could subdue even the most severe pains. After the war, Beecher established a major prog r a m m e of research at Harvard Medical School, which subsequently inspired hundreds of other scientists around the world to explore the miraculous p o w e r of placebos. A s the t w e n t i e t h c e n t u r y
progressed, research
into p l a c e b o
responses threw up s o m e rather shocking results. In particular, it soon b e c a m e clear that s o m e well-established treatments benefited patients largely because of the placebo effect. For e x a m p l e , in 1986 a study w a s conducted with patients w h o had undergone tooth extraction, and w h o then had their j a w massaged by an applicator generating ultrasound. T h e s e sound w a v e s , w h o s e frequency is too high to be heard, could apparently reduce post-operative swelling and pain. U n k n o w n to the patients or the therapists, the researchers tampered with the apparatus so that there was no ultrasound during half of the sessions. Because nobody can hear ultrasound, those patients not receiving ultrasound did not suspect that anything was w r o n g . Astonishingly, patients described similar amounts of pain relief regardless of whether the ultrasound was on or off. It seemed that the effect of the ultrasound treatment was wholly or largely d u e to the placebo effect and had little to do with whether the e q u i p m e n t was working. Thinking back to
58
TRICK OR TREATMENT?
Haygarth's criteria for a good p l a c e b o , we can see that the ultrasound equipment fits the bill - dentists had promoted it as effective, it looked expensive and it was novel. An even more startling e x a m p l e relates to an operation k n o w n as internal m a m m a r y ligation, which was used to relieve the pain of angina. T h e pain is caused by a lack of o x y g e n , which itself is caused by insufficient blood running through the narrowed coronary arteries. T h e surgery in question w a s supposed to tackle the p r o b l e m by blocking the internal m a m m a r y artery in order to force m o r e blood into the coronary arteries. T h o u s a n d s of patients underwent the operation and afterwards stated that they suffered less pain and could endure higher levels of exercise. H o w e v e r , s o m e cardiologists b e c a m e sceptical, because autopsies on patients w h o eventually died revealed no signs of any extra blood flow through the remaining coronary arteries. If there was no significant i m p r o v e m e n t in blood flow, then what w a s causing the patients to improve? C o u l d the relief of s y m p t o m s be d u e simply to the placebo effect? To find out, a cardiologist named L e o n a r d C o b b conducted a trial in the late 1950s that today seems shocking. Patients with angina were divided into t w o g r o u p s , one of which underwent the usual internal m a m m a r y ligation, while the other group received sham surgery; this m e a n s that an incision w a s m a d e in the skin and the arteries were e x p o s e d , but no further surgery w a s conducted. It is important to point out that patients had no idea whether they had undergone the real or sham surgery, as the superficial scar was the same for both. Afterwards, roughly three-quarters of the patients in both groups reported significantly lower levels of pain, accompanied by higher exercise tolerance. Incredibly, because both real and sham operations were equally successful, then the surgery itself must have been ineffective and any benefit to the patient must have been induced by a powerful placebo effect. Indeed, the placebo effect was so great that it allowed patients in both groups to reduce their intake of medication. Although this suggests that the placebo effect is a force for good, it is important to remember that it can have negative consequences. For example, imagine a patient w h o feels better because of a placebo response to an otherwise ineffective treatment - the underlying problem would still
THE TRUTH A B O U T ACUPUNCTURE
59
persist, and further treatment might still be necessary, but the temporarily improved patient is less likely to seek that treatment. In the case of m a m mary ligation, the underlying problem of narrowed arteries and lack of oxygen supply still existed in patients, so they were probably lulled into a false sense of security. So far, it would be easy to think that the placebo effect is restricted to reducing the experience of pain, perhaps by increasing the patient's pain threshold through placebo-induced will power. Such a view would underestimate the p o w e r and scope of the placebo effect, which works for a wide range of conditions, including insomnia, nausea and depression. In fact, scientists h a v e observed real physiological changes in the body, suggesting that the placebo effect goes far b e y o n d the patient's mind by also impacting directly on physiology. Because the placebo effect can be so dramatic, scientists h a v e been keen to understand exactly h o w it influences a patient's health. O n e theory is that it might be related to unconscious conditioning, otherwise k n o w n as the Pavlovian response, n a m e d after Ivan Pavlov. In the 1890s Pavlov noticed that dogs not only salivated at the sight of food, but also at the sight of the person w h o usually fed t h e m . He considered that salivating at the sight of food was a natural or unconditioned response, but that salivating at the sight of the feeder was an unnatural or conditioned r e s p o n s e , which existed only because the dog had c o m e to associate the sight of the person w h o fed it with the provision of food. Pavlov w o n d e r e d if he could create other conditioned responses, such as ringing a bell prior to the provision of food. Sure e n o u g h , after a while the conditioned dogs w o u l d salivate at the sound of the bell alone. T h e importance of this work is best reflected by the fact that Pavlov went on to win the Nobel Prize for Medicine in 1904. Whilst such conditioned salivation might seem very different from the placebo effect on health, w o r k by other Russian scientists then went on to show that e v e n an animal's i m m u n e response could be conditioned. Researchers worked with guinea pigs, which were k n o w n to develop a rash w h e n injected with a certain mildly toxic substance. To see if the rash could be initiated through conditioning, they began lightly scratching the guinea pigs prior to giving an injection. Sure e n o u g h , they later discovered that merely scratching the skin and not
60
TRICK OR TREATMENT?
giving the injection could stimulate the same redness and swelling. This was extraordinary - the guinea pig responded to scratching as if it were being injected with the toxin, simply because it had been conditioned to associate strongly the scratching with the consequences of the injection. S o , if the placebo effect in h u m a n s is also a conditioned r e s p o n s e , then the explanation for its effectiveness would be that a patient simply associates getting better with, for e x a m p l e , seeing a doctor or taking a pill. After all, ever since childhood a patient will h a v e visited a doctor, received a pill and then felt better. H e n c e , if a doctor prescribes a pill containing no active ingredient, a so-called sugar pill, then the patient might still experience a benefit d u e to conditioning. Another explanation for the placebo effect is called the expectation theory. This theory holds that if we expect to benefit from a treatment, then we are more likely to do so. W h e r e a s conditioning would exploit our unconscious minds to provoke a placebo response, the expectation theory suggests that our conscious mind might also be playing a role. T h e expectation theory is supported by a host of data from m a n y lines of research, but it is still poorly understood. O n e possibility is that our expectations are s o m e h o w interacting with our b o d y ' s so-called acute phase
response.
T h e acute phase response covers a range of bodily reactions, such as pain, swelling, fever, lethargy and loss of appetite. In short, the acute phase response is the umbrella term used to describe the b o d y ' s emergency defensive response to being injured. For instance, the reason that we experience pain is that our body is telling us that we have suffered an injury, and that we need to protect and nurture that part of the body. The experience of swelling is also for our o w n g o o d , because it indicates an increased blood flow to the injured region, which will accelerate healing. T h e increased body temperature associated with fever will help kill invading bacteria and provide ideal conditions for our o w n i m m u n e cells. Similarly, lethargy aids recovery by encouraging us to get much-needed rest, and a loss of appetite encourages even more rest because we have suppressed the need to hunt for food. It is interesting to note that the placebo effect is particularly good at addressing issues such as pain, swelling, fever,
THE TRUTH A B O U T ACUPUNCTURE
61
lethargy and loss of appetite, so perhaps the placebo effect is partly the consequence of an innate ability to block the acute phase response at a fundamental level, possibly by the p o w e r of expectation. T h e placebo effect m a y be linked to either conditioning or expectation or both, and there m a y be other even m o r e important m e c h a n i s m s that have yet to be identified or fully appreciated. W h i l e scientists strive to establish the scientific basis of the placebo effect, they h a v e already been able to ascertain, by building on H a y g a r t h ' s early w o r k , h o w to m a x i m i z e it. It is k n o w n , for instance, that a drug administered by injection has a bigger placebo effect than the same drug taken in pill form, and that taking t w o pills provokes a greater placebo response than taking just o n e . M o r e surprisingly, green pills h a v e the strongest placebo effect on relieving anxiety, whereas yellow pills w o r k best for depression. M o r e o v e r , a pill's placebo effect is increased if it is given by a doctor wearing a white coat, but it is reduced if it is administered by a doctor wearing a T-shirt, and it is even less effective if given by a nurse. Large tablets offer a stronger p l a c e b o effect than small tablets . . . unless the tablets are very, very small. Not surprisingly, tablets in fancy branded packaging give a bigger placebo effect than those in plain packets. Of c o u r s e , all of the above statements refer to the average patient, because the actual placebo effect for a particular patient depends entirely on the belief system and personal e x p e r i e n c e s of that individual. This variability of placebo effect a m o n g patients, and its potentially powerful influence on recovery, m e a n s that it can be a highly misleading factor w h e n it c o m e s to assessing the true efficacy of a treatment. In fact, the placebo effect is so unpredictable that it could easily distort the results of a clinical trial. Therefore, in order to test the true value of a c u p u n c t u r e (and m e d i c i n e s in g e n e r a l ) , researchers s o m e h o w needed to take into account the quirky, erratic and sometimes strong influence of the placebo effect. T h e y would succeed in this e n d e a v o u r by developing an almost foolproof form of the clinical trial.
62
TRICK OR TREATMENT?
The blind leading the double-blind T h e simplest form of clinical trial involves a group of patients w h o receive a new treatment being c o m p a r e d against a group of similar patients w h o receive no treatment. Ideally there should be a large n u m b e r of patients in each group and they should be r a n d o m l y assigned. If the treated group then shows m o r e signs of recovery on average than the untreated control g r o u p , then the n e w treatment is having a real impact . . . or is it? We must n o w also consider the possibility that a treatment might have appeared to be effective in the trial, but only because of the placebo effect. In other w o r d s , the group of patients being actively treated might expect to recover simply because they are receiving some form of medical intervention, thus stimulating a beneficial placebo response. H e n c e , the straightforward trial design can produce misleading results, because even a useless treatment can give positive results in such a trial. So the question arises: h o w do we design a clinical trial that takes into account the confusion caused by the placebo effect? A solution can be traced back to eighteenth-century France and the extraordinary claims of Franz Mesmer. Whilst M e s m e r is n o w a d a y s associated with hypnotism (or m e s m e r i s m ) , in his o w n lifetime he was most famous for promoting the health benefits of m a g n e t i s m . He argued that he could cure patients of many illnesses by manipulating their 'animal m a g n e t i s m ' , and o n e of the w a y s of doing this was to give them magnetically treated water. T h e r e m e d y was very d r a m a t i c , because sometimes the supposedly magnetized water could induce fits or fainting as part of the alleged healing process. Critics, however, doubted that water could be magnetized and they were also dubious about the notion that m a g n e t i s m could affect h u m a n health. T h e y suspected that the reactions of M e s m e r ' s patients were purely based on their faith in his claims. In modern parlance, critics were suggesting that M e s m e r ' s remedies were exploiting the placebo effect. In
1 7 8 5 , L o u i s X V I c o n v e n e d a Royal C o m m i s s i o n to test
M e s m e r ' s claims. This
Commission, which
included
Benjamin
Franklin, conducted a series of experiments in which one m e s m e r i z e d
T H E TRUTH A B O U T ACUPUNCTURE
glass of water w a s placed a m o n g four glasses of plain water - all five glasses looked identical. U n a w a r e which glass was w h i c h , volunteers then randomly picked one glass of water and drank it. In one case, a female patient tasted her glass and immediately fainted, but it was then revealed that she had drunk only plain water. It seemed obvious that the fainting w o m a n thought that she was drinking magnetized water, she k n e w what w a s supposed to happen when people drank such water, and her body responded appropriately. After
all
the
experiments
had
been
completed,
the
Royal
C o m m i s s i o n could see that patients had responded in a similar way regardless of whether the water was plain or magnetized. Therefore, they concluded that magnetized water was the same as plain water, which meant that the term magnetized water did not really mean anything. Moreover, the C o m m i s s i o n stated that the effect of supposedly magnetized water was due to the expectation of patients; today we would say that it was due to the placebo effect. In short, the C o m m i s s i o n accused M e s m e r ' s therapy of being fraudulent. T h e Royal C o m m i s s i o n did not, however, speculate about the widespread effects of p l a c e b o t h r o u g h o u t m e d i c i n e , w h i c h
is w h y
Haygarth's research on tractors fourteen years later is credited with formally recognizing the role of the placebo effect in medical practice. On the other hand, the Royal Commission did make a major contribution to the history of medicine, because it had designed a new type of clinical trial. The key breakthrough in the Royal Commission's experiment was that the patients were unaware of whether or not they were receiving the real or fake treatment, because the glasses of mesmerized water and plain water were identical. The patients were said to be blind. T h e concept of blinding can be applied to entire trials, which are k n o w n as blinded clinical trials. For e x a m p l e , if a n e w pill is being tested then it is given to all the patients in the treatment g r o u p , while a pill that looks the same but without any active ingredient is given to the control g r o u p . Importantly, patients have no idea if they are in the treatment or control g r o u p , so they remain blind as to whether or not they are being treated. It is quite possible that both groups will show signs of improvement if both respond to the placebo effect caused by the possibility of receiving the real pill. H o w e v e r , the treatment group
64
TRICK OR TREATMENT?
should show greater signs of i m p r o v e m e n t than the control group if the real pill has a genuine effect beyond placebo. In a blinded trial, it is crucial that both the control group and the treatment group are treated in similar w a y s , because any variation can potentially affect the recovery of patients and bias the results of the trial. Therefore, as well as receiving pills that look the s a m e , patients in both groups should also be treated in the same location, be given the same level of attention and so o n . All these factors can contribute to socalled non-specific effects - n a m e l y effects resulting from the context of the treatment process, but which are not directly due to the treatment itself. Non-specific effects is the umbrella term that also covers the placebo effect. It is even necessary to monitor patients in both groups in exactly the same way, because it has been shown that the act of close monitoring can lead to a generally positive c h a n g e in a person's health or performance. This is k n o w n as the H a w t h o r n e effect, a t e r m that w a s coined after researchers visited the H a w t h o r n e Plant in Illinois, part of the Western Electric C o m p a n y . T h e researchers wanted to see h o w the working environment affected the plant's output, so between 1927 and 1932 they increased artificial illumination and then reduced it, they increased r o o m temperature and then reduced it, and so on. T h e researchers were amazed to find that any c h a n g e seemed to cause an improvement. This was partly because workers expected that the changes were supposed to bring about i m p r o v e m e n t s , and partly because they knew they were being monitored by experts with clipboards. It is difficult to r e m o v e the H a w t h o r n e effect in any medical trial, but at least the effect should be the same for both the treatment group and the control group so that a fair comparison can be m a d e . Creating identical conditions for the control and the treatment groups effectively blinds the patients to whether or not they are receiving the treatment or the placebo. Yet it is also important to blind whoever is administering the treatment or the placebo. In other w o r d s , even the doctors treating the patients should not be aware of whether they are giving a sugar pill or an active pill. This is because a d o c t o r ' s demeanour, enthusiasm and tone of voice can all be affected by k n o w ing that he or she is administering a placebo, which m e a n s that the
THE TRUTH A B O U T ACUPUNCTURE
65
doctor might unconsciously give hints to patients that the medicine is merely a p l a c e b o . Such leaking of information, of c o u r s e , can jeopardize the blinding of the patient and the overall reliability of the clinical trial. T h e consequence would be that patients in the placebo control group would suspect that they were receiving a placebo and would then fail to exhibit a placebo response. Perversely, patients receiving the real treatment would have no such q u a l m s and w o u l d exhibit a placebo r e s p o n s e . H e n c e , the trial would be unfair. If, however, both the patient and the doctor are u n a w a r e of whether a placebo or a supposedly active treatment is being administered, then the trial results cannot be influenced by the expectation of either. This type of truly fair trial is said to be double-blind. Including some of the points m a d e in Chapter 1, we can n o w see that a well-conducted trial ideally requires several key features: 1. A comparison between a control group and a g r o u p receiving the treatment being tested. 2. A sufficiently large n u m b e r of patients in each g r o u p . 3. R a n d o m assignment of patients to each group. 4. T h e administering of a placebo to the control g r o u p . 5. Identical conditions for the control and treatment g r o u p s . 6. Blinding patients so that they are u n a w a r e to which group they belong. 7. Blinding doctors so that they are unaware whether they are giving a real or a placebo treatment to each patient. A trial that includes all these features is k n o w n as a r a n d o m i z e d , placebo-controlled, double-blind clinical trial, and it is considered to be the highest possible standard of medical testing. N o w a d a y s , the various national bodies responsible for authorizing new treatments will usually m a k e their decisions based on the results obtained from such studies. S o m e t i m e s , however, it is necessary to conduct trials that are closely related to this format, but which do not involve a placebo. For e x a m p l e , imagine that scientists want to test a new drug for a condition that is already treated with a partly effective existing drug. Point 3
66
TRICK OR TREATMENT?
indicates that the control group receives only a p l a c e b o , but this would be unethical if it deprived patients of the partly effective d r u g . In this situation, the control group w o u l d receive the existing drug and the o u t c o m e would be compared against the other group receiving the new drug - the trial would not be placebo-controlled, but there w o u l d still be a control, namely the existing drug. S u c h a trial should still adhere to all the other requirements, such as randomization and doubleblinding. These sorts of clinical trials are invaluable w h e n conducting medical research. Although the results from other types of trial and other evidence might be considered, they are generally d e e m e d to be less convincing when it c o m e s to the key question: is a treatment effective for a particular condition? Returning to acupuncture, we can re-examine the clinical trials of the 1970s and 1980s - were these trials of high quality and were they properly blinded, or is it possible that the reported benefits of acupuncture were due merely to the placebo effect? A good e x a m p l e of the type of acupuncture trial that took place during this period was one conducted in 1982 by Dr Richard Coan and his t e a m , w h o wanted to e x a m i n e whether or not acupuncture w a s effective for neck pain. His treatment group consisted of fifteen patients w h o received acupuncture, while his control group consisted of another fifteen patients w h o remained on a waiting list. T h e results would have seemed unequivocal to fans of acupuncture, because 80 per cent of patients in the acupuncture group reported an i m p r o v e m e n t , compared to only 13 per cent of the control g r o u p . T h e extent of the pain relief in the acupuncture group was so great that they halved their intake of painkillers, whereas the control group reduced their intake of pills by only one tenth. C o m p a r i n g the acupuncture group against the control g r o u p shows that the improvement due to acupuncture is m u c h greater than can be explained by any natural recovery. H o w e v e r , was the benefit from acupuncture due to psychological or physiological factors or a mix of the t w o ? Did the acupuncture trigger a genuine healing m e c h a n i s m , or did it merely stimulate a placebo response? T h e latter possibility has to be treated seriously, because acupuncture has m a n y of the attributes
T H E TRUTH A B O U T ACUPUNCTURE
67
that would m a k e it an ideal placebo treatment: needles, mild pain, the slightly invasive nature, exoticism, a basis in ancient w i s d o m and fantastic press c o v e r a g e . So Dr C o a n ' s clinical trial, along with m a n y of the others conducted in the 1970s and 1980s, suffered from the p r o b l e m that they could not determine whether acupuncture w a s offering a real benefit or merely a placebo benefit. T h e ideal w a y to find out whether acupuncture w a s genuinely effective w o u l d h a v e been to give a placebo to the control g r o u p , something that seemed identical to acupuncture but which was totally inert. Unfortunately, finding such a placebo proved difficult h o w can you create a therapy that appears to be acupuncture but which is not actually acupuncture? H o w do you blind patients to whether or not they are receiving acupuncture? Placebo control groups are easy to arrange in the context of conventional drug trials, because the treatment group c a n , say, receive a pill with the active ingredient and the placebo control group can receive an identical-looking pill without the active ingredient. Or the treatment group can receive an injection of the active drug and the placebo control group can receive an injection of saline. Unfortunately, there was no similarly obvious placebo replacement for acupuncture. Gradually, however, researchers began to realize that there were t w o w a y s of m a k i n g patients believe that they w e r e receiving real acupuncture, when they w e r e in fact receiving fake acupuncture. O n e option was to needle patients to only a minimal depth, as opposed to the centimetre or m o r e that most practitioners would use. T h e purpose of this superficial needling was that it seemed like the real thing to patients w h o had not previously experienced genuine acupuncture, but according to the Chinese theory it should have no medical benefit b e c a u s e the n e e d l e s
w o u l d not r e a c h the m e r i d i a n . T h e r e f o r e
researchers proposed studies in which a control group would receive superficial needling, while a treatment group would receive real acupuncture. Both groups w o u l d receive similar levels of placebo benefit, but if real acupuncture has a real physiological effect then the treatment group should receive a significant extra benefit b e y o n d that received by the control g r o u p . Another attempt at placebo acupuncture involved needling at points
68
TRICK OR TREATMENT?
that are not acupuncture points. Such points traditionally have nothing to do with a patient's health. This misplaced needling would s e e m like genuine acupuncture to new patients, but according to the Chinese theory misplaced needling should have no medical benefit because it would miss the meridians. H e n c e , some trials were planned in which the control group would receive misplaced needling and the treatment group would receive genuine acupuncture. Both groups w o u l d receive the benefit of the placebo effect, but any extra i m p r o v e m e n t in the treatment group could then be attributed to acupuncture. These t w o forms of placebo acupuncture, misplaced and superficial, are often termed sham needling. During the 1990s, sceptics pushed for a major reassessment of acupuncture, this time with placebo-controlled clinical trials involving sham needling. For m a n y acupuncturists, such research was redundant because they had seen h o w their o w n patients had responded so positively. T h e y argued that the evidence in favour of their treatment was already compelling. W h e n critics continued to demand placebo-controlled trials, the acupuncturists accused t h e m of clutching at straws and of being prejudiced against alternative medicine. Nevertheless, those medical researchers w h o believed in the authority of the placebo-controlled trial refused to back d o w n . T h e y continued to voice their doubt and argued that acupuncture would remain a dubious therapy until it had proved itself in high-quality clinical trials. T h o s e d e m a n d i n g proper acupuncture trials eventually had their wish granted
when
major funding enabled d o z e n s
of p l a c e b o -
controlled clinical trials to take place in E u r o p e and A m e r i c a throughout the 1990s. Each trial w a s to be conducted rigorously in the hope that the results would shed new light on w h o was right and w h o was w r o n g . Was acupuncture a miracle medicine that could treat everything from colour blindness to w h o o p i n g c o u g h , or was it nothing more than a placebo?
Acupuncture on trial By the end of the twentieth century a n e w batch of results began to emerge from the latest clinical trials on acupuncture. In general these
THE TRUTH A B O U T ACUPUNCTURE
69
trials were of higher quality than earlier trials, and some of them examined the impact of acupuncture on conditions that had not previously been tested. With so m u c h new information, the W H O decided that it would take up the challenge of summarizing all the research and presenting some conclusions. Of c o u r s e , the W H O had already published a s u m m a r y d o c u m e n t in 1979, which had b e e n very positive about a c u p u n c t u r e ' s ability to treat m o r e than twenty c o n d i t i o n s , but they w e r e k e e n to revisit the situation in light of the new data that was e m e r g i n g . T h e W H O t e a m eventually took into consideration the results from 2 9 3 research papers and published their conclusions in 2003 in a report entitled Acupuncture:
Review
and
analysis
of reports
on
controlled
clinical
trials. T h e n e w report assessed the a m o u n t and quality of evidence to support the use of acupuncture for a whole series of c o n d i t i o n s , and it s u m m a r i z e d its conclusions by dividing diseases and disorders into four categories. T h e first category contained conditions for which there was the most c o n v i n c i n g evidence in favour of using a c u p u n c ture and the fourth contained conditions for which the e v i d e n c e was least convincing:
1
Conditions 'for which acupuncture has been proven - through controlled trials - to be an effective treatment' - this included twenty-eight conditions ranging from morning sickness to stroke.
2
Conditions 'for which the therapeutic effect of acupuncture has been shown but for which further proof is needed' - this included sixty-three conditions ranging from abdominal pain to whooping cough.
3
Conditions 'for which there are only individual controlled trials reporting some therapeutic effects, but for which acupuncture is worth trying because treatment by conventional and other therapies is difficult' - this included nine conditions, such as colour blindness and deafness.
70
TRICK OR TREATMENT?
4
Conditions 'for which acupuncture may be tried provided the practitioner has special modern medical knowledge' - this included seven conditions, such as convulsions in infants and coma. T h e 2003 W H O report concluded that the benefits of acupuncture
were either ' p r o v e n ' or 'had been s h o w n ' in the treatment of ninetyone conditions. It was mildly positive or equivocal about a further sixteen c o n d i t i o n s . And the report did not exclude the use of acupuncture for any conditions. T h e W H O had given acupuncture a ringing endorsement, reinforcing their 1979 report. It would be natural to assume that this was the final word in the debate over a c u p u n c t u r e , b e c a u s e the W H O is an international authority on medical issues. It w o u l d seem that acupuncture had shown itself to be a powerful medical therapy. In fact, the situation is not so clear cut. Regrettably, as we shall see, the 2003 W H O report w a s shockingly misleading. The W H O had made two major errors in the way that it had judged the effectiveness of acupuncture. The first error was that they had taken into consideration the results from too many trials. This seems like a perverse criticism, because it is generally considered good to base a conclusion on lots of results from lots of trials involving lots of patients - the more the merrier. If, however, some of the trials have been badly conducted, then those particular results will be misleading and may distort the conclusion. Hence, the sort of overview that the W H O was trying to gain would have been more reliable had it implemented a certain level of quality control, such as including only the most rigorous acupuncture trials. Instead, the W H O had taken into consideration almost every trial ever conducted, because it had set a relatively low quality threshold. Therefore, the final report was heavily influenced by untrustworthy evidence. T h e second error was that the W H O had taken into consideration the results of a large n u m b e r of acupuncture trials originating from C h i n a , whereas it would have been better to have excluded t h e m . At first sight, this rejection of Chinese trials might seem unfair and discriminatory, but there is a great deal of suspicion surrounding acupuncture research in China. For e x a m p l e , let's look at acupuncture in the t r e a t m e n t of a d d i c t i o n . R e s u l t s
from Western trials of
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71
acupuncture include a mixture of mildly positive, equivocal or negative results, with the overall result being negative on balance. By contrast, Chinese trials examining the same intervention always give positive results. This does not m a k e sense, because the efficacy of acupuncture should not depend on whether it is being offered in the Eastern or Western h e m i s p h e r e . Therefore, either Eastern researchers or Western researchers must be wrong - as it h a p p e n s , there are good reasons to believe that the p r o b l e m lies in the East. T h e crude reason for blaming Chinese researchers for the discrepancy is that their results are simply too good to be true. This criticism has been confirmed by careful statistical analyses of all the Chinese results, which d e m o n strate beyond all reasonable doubt that Chinese researchers are guilty of so-called publication
bias.
Before explaining the meaning of publication bias, it is important to stress that this is not necessarily a form of deliberate fraud, because it is easy to conceive of situations when it can occur d u e to an unconscious pressure to get a particular result. Imagine a Chinese researcher w h o conducts an acupuncture trial and achieves a positive result. Acupuncture is a major source of prestige for China, so the researcher quickly and proudly publishes his positive result in a j o u r n a l . He m a y even be promoted for his w o r k . A year later he conducts a second similar trial, but on this occasion the result is negative, which is obviously disappointing. T h e key point is that this second piece of research might never be published for a whole range of possible reasons: m a y b e the researcher does not see it as a priority, or he thinks that nobody will be interested in reading about a negative result, or he persuades himself that this second trial must have been badly conducted, or he feels that this latest result would offend his peers. W h a t e v e r the reason, the researcher ends up having published the positive results of the first trial, while leaving the negative results of the second trial buried in a drawer. This is publication bias. W h e n this sort of p h e n o m e n o n is multiplied across C h i n a , then we have dozens of published positive trials, and dozens of unpublished negative
trials.
Therefore,
when
the
WHO
conducted
a
review of the published literature that relied heavily on Chinese research its conclusion w a s bound to be skewed - such a review
72
TRICK OR TREATMENT?
could never take into account the unpublished negative trials. T h e W H O report was not just biased and misleading; it w a s also dangerous because it was endorsing acupuncture for a whole range of conditions, some of which were serious, such as coronary heart disease. This begs the question, h o w and w h y did the W H O write a report that was so irresponsible? T h e W H O has an excellent record w h e n it c o m e s to conventional medicine, but in the area of alternative medicine it seems to prioritize political c o r r e c t n e s s a b o v e truth. In o t h e r w o r d s , c r i t i c i s m of acupuncture might be perceived as criticism of C h i n a , of ancient wisdom and of Eastern culture as a w h o l e . Moreover, usually w h e n expert panels are assembled in order to review scientific research, the protocol is to include experts with informed but diverse opinions. A n d , crucially, the panel should include critical thinkers w h o question and challenge any assumptions; otherwise the panel's deliberations are a meaningless waste of time and money. H o w e v e r , the W H O a c u p u n c ture panel did not include a single critic of acupuncture. It w a s quite simply a group of believers w h o unsurprisingly were less than objective in their assessment. M o s t worrying of all, the report was drafted and revised by Dr Z h u - F a n X i e , w h o was Honorary Director of the Institute of Integrated Medicines in Beijing, which fully endorses the use of acupuncture for a range of disorders. It is generally inappropriate for s o m e o n e with such a strong conflict of interest to be so closely involved in writing a medical review. If we cannot trust the W H O to summarize adequately the vast number of clinical trials concerning acupuncture, then to whom do we turn? Fortunately, several academics around the world have made up for the W H O ' s failure by providing their o w n summaries of the research. Thanks to these groups, we can at long last answer the question that has lingered throughout this chapter - is acupuncture effective?
The Cochrane Collaboration Doctors are confronted each year with hundreds of new results from clinical trials, which might cover everything from re-testing an
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73
existing m a i n s t r e a m treatment to initial testing of a controversial alternative therapy. Often there will be several trials focused on the same treatment for the s a m e ailment, and results can be difficult to interpret and s o m e t i m e s contradictory. With not e n o u g h hours in the day to deal with patients, it would be impractical and nonsensical for doctors to read through each research paper and c o m e to their o w n conclusions. Instead, they rely heavily on those a c a d e m i c s w h o devote themselves to m a k i n g sense of all this research, and w h o p u b lish conclusions that help doctors advise patients about the best form of treatment. Perhaps the most famous and respected authority in this field is the C o c h r a n e Collaboration, a global network of experts coordinated via its headquarters in Oxford. Firmly adhering to the principles of evidence-based m e d i c i n e , the C o c h r a n e Collaboration sets itself the goal of examining clinical trials and other medical research in order to offer digestible conclusions about which treatments are genuinely effective for w h i c h c o n d i t i o n s .
Before
revealing
the C o c h r a n e
Collaboration's findings on acupuncture, we will first briefly look at its origins and h o w it c a m e to be held in such high regard. In this way,
by
establishing
the
Cochrane Collaboration's reputation, we h o p e that you will accept their conclusions about acupuncture in due course. T h e Cochrane Collaboration is named after Archie Cochrane, a Scotsman w h o abandoned his medical
studies at University
College H o s p i t a l , L o n d o n , in 1936 to serve in the Spanish Civil War as part of a Field Ambulance Unit. Then in the Second World War he joined the Royal Army Medical Corps as a Archie Cochrane
74
TRICK OR TREATMENT?
captain and served in Egypt, but
he was captured in 1941 and spent the rest of the war providing medical help to fellow prisoners. This was when he first became aware of the importance of evidence-based medicine. He later wrote that the prison authorities would encourage him by claiming that he was at liberty to decide how to treat his patients: 'I had considerable freedom of choice of therapy: my trouble was that I did not know which to use and when. I would gladly have sacrificed my freedom for a little knowledge.' In order to arm himself with more knowledge he conducted his o w n trials among his fellow prisoners - he earned their support by telling them about James Lind and the role of clinical trials in working out the best treatment for patients with scurvy. Whilst C o c h r a n e was clearly a fervent advocate of the scientific method and clinical trials, it is important to note that he also realized the medical value of h u m a n c o m p a s s i o n , as demonstrated by numerous events throughout his life. O n e of the most poignant e x a m p l e s occurred during his time as a prisoner of war at Elsterhorst, G e r m a n y , when he found himself in the hopeless position of treating a Soviet prisoner w h o was ' m o r i b u n d and s c r e a m i n g ' . All C o c h r a n e could offer was aspirin. As he later recalled: I finally instinctively sat down on the bed and took him in my arms, and the screaming stopped almost at once. He died peacefully in my arms a few hours later. It was not the pleurisy that caused the screaming but loneliness. It was a wonderful education about the care of the dying. After the war, Cochrane went on to have a distinguished career in medical research. This included studying pneumoconiosis in the coal miners of South Wales and becoming Professor of Tuberculosis and Chest Diseases at the Welsh National School of Medicine in 1960. As his career progressed, he became even more passionate about the value of evidence-based medicine and the need to inform doctors about the most effective medicines. At the same time, he realized that doctors struggled to make sense of all the results from all the clinical trials that were being conducted around the world. Hence Cochrane argued that medical progress would be best served if an organization could be established with the responsibility of drawing clear-cut conclusions from the myriad research projects. In 1979 he wrote,
THE TRUTH A B O U T ACUPUNCTURE
75
'It is surely a great criticism of our profession that we have not organised a critical summary, by speciality or subspecialty, adapted periodically, of all relevant randomised controlled trials.' T h e key phrase in C o c h r a n e ' s statement w a s 'a critical s u m m a r y ' , which implied that w h o e v e r w a s doing the s u m m a r y ought to assess critically the value of each trial in order to determine to what extent it should contribute to the final conclusion about whether a particular therapy is effective for a particular condition. In other w o r d s , a carefully conducted trial with lots of patients should be taken seriously; a less carefully conducted trial with just a few patients should carry less weight; and a poorly conducted trial should be ignored completely. This type of approach w o u l d b e c o m e k n o w n as a systematic review. It is a rigorous scientific evaluation of the clinical trials relating to a particular treatment, as opposed to the sort of reports that the W H O w a s publishing on a c u p u n c t u r e , which were little more than casual uncritical overviews. An evidence-based approach to m e d i c i n e , as previously discussed, m e a n s looking at the scientific evidence from clinical trials and other sources in order to decide best medical practice. T h e systematic review is often the final stage of evidence-based medicine, whereby a conclusion is drawn from all the available evidence. Archie C o c h r a n e died in 1988, by which time the ideas of evidence-based medicine and systematic reviews had taken hold in m e d i c i n e , but it w a s not until 1993 that his vision was fully realized with the establishment of the C o c h r a n e Collaboration. Today it consists of twelve centres around the world and over
10,000 health expert volunteers from over
ninety countries, w h o trawl through clinical trials in order 'to help people m a k e well-informed decisions by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of interventions in all areas of health c a r e ' . H a v i n g b e e n in e x i s t e n c e for o v e r a d e c a d e , the C o c h r a n e Collaboration has by n o w accumulated a library consisting of the results of thousands of trials and has published hundreds of systematic r e v i e w s . As well as providing j u d g e m e n t s on the effectiveness of pharmaceutical d r u g s , these systematic reviews evaluate all sorts of other treatments, as well as preventative measures, the value of screening,
76
TRICK O R TREATMENT?
and the impact of lifestyle and diet on health. In each case, the wholly independent C o c h r a n e Collaboration presents its conclusions about the effectiveness of whatever is being systematically reviewed. Hopefully this background to the C o c h r a n e Collaboration has helped to convey its reputation for i n d e p e n d e n c e , rigour and quality. This means that we can n o w look at their systematic reviews of acupuncture and can confidently a s s u m e that their conclusions are very likely to be accurate. T h e C o c h r a n e Collaboration has published several systematic reviews relating to the impact of acupuncture on a variety of conditions, focusing largely on the evidence from placebocontrolled clinical trials. First, here is the bad n e w s for acupuncturists. T h e C o c h r a n e reviews suggest that there is no significant evidence to show that acupuncture is an effective treatment for any of the following conditions: smoking addiction, cocaine d e p e n d e n c e , induction of labour, Bell's palsy, chronic asthma, stroke rehabilitation, breech presentation, depression, epilepsy, carpal tunnel s y n d r o m e , irritable bowel s y n d r o m e , schizophrenia, rheumatoid arthritis, insomnia, non-specific back pain, lateral elbow pain, shoulder pain, soft tissue shoulder injury, morning sickness, e g g collection, g l a u c o m a , vascular d e m e n t i a , period pains, whiplash injury and acute stroke. H a v i n g e x a m i n e d scores of clinical trials, the C o c h r a n e reviews conclude that any perceived benefit from acupuncture for these conditions is merely a placebo effect. T h e summaries contain the following sorts of conclusions:
'Acupuncture and related therapies do not appear to help smokers who are trying to quit.' 'There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence.' 'There is insufficient evidence describing the efficacy of acupuncture to induce labour.' "The current evidence does not support acupuncture as a treatment for epilepsy.'
T H E TRUTH A B O U T ACUPUNCTURE
77
1 A l s o , the C o c h r a n e reviews regularly criticize the quality of the research conducted to date, with c o m m e n t s such as: ' T h e quality of the
i n c l u d e d trials
was
inadequate to
allow
any
conclusion.'
W h e t h e r the trials w e r e reliable or unreliable, the upshot is the same: despite thousands of years of use in China and decades of scientific research from m a n y countries, there is no sound evidence to support the use of acupuncture for any of the disorders n a m e d a b o v e . This is particularly worrying in light of the sort of treatments currently being offered by m a n y acupuncture clinics. F o r e x a m p l e , by searching for a UK acupuncturist on the w e b and clicking on the first advert, it w a s simple to find a central L o n d o n clinic offering acupuncture for the treatment of all of the following conditions: addictions, anxiety, circulatory p r o b l e m s , depression, diabetes, facial rejuvenation, fatigue, gastrointestinal p r o b l e m s , hay fever, heart p r o b l e m s , high blood pressure, six categories of infertility, insomnia, kidney disorders, liver disease, menopausal p r o b l e m s , menstrual p r o b l e m s , pregnancy c a r e , birth induction, m o r n i n g sickness, breech presentation, respiratory conditions, r h e u m a t i s m , sexual p r o b l e m s , sinus p r o b l e m s , skin p r o b l e m s , stress-related illness, urinary problems and weight loss. T h e s e conditions fall into o n e of three categories:
1
Cochrane reviews deem that the evidence from clinical trials does not show acupuncture to be effective.
2
Cochrane reviews conclude that the clinical trials have been so poorly conducted that nothing can be said about the effectiveness of acupuncture with any confidence.
3
The research is so poor and so minimal that the Cochrane Collaboration has not even bothered conducting a systematic review. Moreover, systematic reviews by other institutions and universities
c o m e to exactly the s a m e sort of conclusions arrived at by the C o c h r a n e Collaboration. Despite the fact that there is no reason to believe that it w o r k s for any of these conditions, except as a p l a c e b o ,
78
TRICK OR TREATMENT?
thousands of clinics in E u r o p e and A m e r i c a are still willing to p r o m o t e acupuncture for such a wide-ranging list of ailments. The good n e w s for acupuncturists is that the C o c h r a n e reviews have been
more positive
about acupuncture's
ability t o treat o t h e r
conditions. There have been cautiously optimistic C o c h r a n e reviews on the treatment of pelvic and back pain during pregnancy, low back pain, h e a d a c h e s , post-operative nausea and vomiting, c h e m o t h e r a p y induced nausea and vomiting, neck disorders and bedwetting. Aside from bedwetting, the only positive conclusions relate to acupuncture in dealing with some types of pain and nausea. Although these particular C o c h r a n e reviews are the most positive about acupuncture's benefits, it is important to note that their support is only half-hearted. For e x a m p l e , in the case of idiopathic h e a d a c h e s , namely those that occur for no k n o w n reason, the review states: 'Overall, the existing evidence supports the value of acupuncture for the treatment of idiopathic h e a d a c h e s . H o w e v e r , the quality and amount of evidence are not fully convincing.' Because the evidence is only marginally positive and not fully convincing, even in the areas of pain and nausea, researchers have focused their efforts on improving the quality and amount of evidence in order to reach a more concrete conclusion. Indeed, one of the authors of this b o o k , Professor Edzard Ernst, has been part of this effort. Ernst, w h o leads the C o m p l e m e n t a r y Medicine Research G r o u p at the University of Exeter, b e c a m e interested in acupuncture when he learned about it at medical school. Since then, he has visited acupuncturists in C h i n a , conducted ten of his o w n clinical trials, published m o r e than forty reviews e x a m i n i n g other acupuncture trials, written a book on the subject and currently sits on the editorial board of several acupuncture journals. This demonstrates his c o m m i t m e n t to investigating with an open mind the value of this form of treatment, while thinking critically and helping to improve the quality of acupuncture trials. O n e of Ernst's most important contributions to improving the quality of trials has been to develop a superior form of sham acupuncture, something even better than misplaced or superficial needling. Figure 1 on page 45 shows h o w an acupuncture device consists of a very fine needle and a broader upper part that is held by the acupuncturist. Ernst
T H E TRUTH A B O U T ACUPUNCTURE
79
and his colleagues proposed the idea of a telescopic needle - that is, an acupuncture needle that looks as if it penetrates the skin, but which instead retracts into the upper handle part, rather like a theatrical dagger. Jongbae Park, a Korean P h D student in Ernst's g r o u p , went ahead and built a prototype, o v e r c o m i n g various problems along the way. F o r e x a m p l e , usually an acupuncture needle stays in place because it is e m b e d d e d in the skin, but the telescopic needle would only appear to penetrate the skin, so h o w would it stay upright? T h e solution was to rely on the plastic guide tube, which acupuncturists often use to help position and ease needle insertion. T h e guide tube is usually r e m o v e d after insertion, but Park suggested making one end of the tube sticky and leaving it in place so that it could support the needle. Park also designed the telescopic system so that the needle offered some resistance as it retracted into the upper handle. This m e a n t that it would cause some minor sensation during its apparent insertion, which in turn would help convince the patient that this was real acupuncture that was being practised. W h e n the Exeter group tested these telescopic needles as part of a placebo acupuncture session, patients were indeed convinced that they were receiving real treatment. T h e y saw the long needle, watched it shorten on impact with the skin, felt a small, localized pain and saw the needle sitting in place for several minutes before being withdrawn. Superficial and misplaced needling were adequate placebos, but an ideal acupuncture placebo should not pierce the skin, which is why this telescopic needling was a superior form of sham therapy. T h e team was delighted to have developed and validated the first true placebo for acupuncture trials, though their pride was tempered when they discovered that t w o G e r m a n research groups at Heidelberg and H a n n o v e r Universities had been working on a very similar idea. Great minds were thinking alike. It has taken several years to design, develop and test the telescopic needle, and it has taken several m o r e years to arrange and conduct clinical trials using it. N o w , however, the first results have begun to emerge from what are arguably the highest-quality acupuncture trials ever conducted.
80
TRICK OR TREATMENT?
These initial conclusions have generally been disappointing for acupuncturists:
they p r o v i d e n o c o n v i n c i n g e v i d e n c e that real
acupuncture is significantly m o r e effective than placebo acupuncture in the treatment of chronic tension h e a d a c h e , nausea after chemotherapy, post-operative nausea and migraine prevention. In other w o r d s , these latest results contradict s o m e of the more positive conclusions from C o c h r a n e r e v i e w s . If these results are repeated in other trials, then it is probable that the C o c h r a n e Collaboration will revise its conclusions and m a k e them less positive. In a way, this is not so surprising. In the past, when trials were poorly conducted, the results for acupuncture seemed positive; but when the trials improved in quality, then the impact of acupuncture seemed to fade away. T h e m o r e that researchers eliminate bias from their trials, the greater the tendency for results to indicate that acupuncture is little more than a placebo. If researchers were able to conduct perfect trials, and if this trend continu e s , then it seems likely that the truth is that acupuncture offers negligible benefit. Unfortunately, it will never be possible to conduct a perfect acupuncture trial, because the ideal trial is double-blind, m e a n i n g that neither the patient nor the practitioner k n o w s if real or placebo treatment is being given. In an acupuncture trial, the practitioner will always k n o w if the treatment is real or a placebo. This might seem unimportant, but there is a risk that the practitioner will unconsciously c o m m u n i c a t e to the patient that a placebo is being administered, perhaps because of the practitioner's body language or tone of voice. It could be that the marginally positive results for acupuncture for pain relief and nausea apparent in some trials are merely due to the slight remaining biases that occur with single blinding. T h e only h o p e for minimizing this problem in future is to give clear and strong guidance to
practitioners
involved
in
trials
to
minimize
inadvertent
communication. While some scientists have focused on the use of telescopic needles in their trials, G e r m a n researchers have concentrated on involving larger n u m b e r s of patients in order to improve the accuracy of their conclusions. G e r m a n interest in testing acupuncture dates back to the late 1990s, when the national authorities voiced serious doubts about
T H E TRUTH A B O U T ACUPUNCTURE
81
the entire field. T h e y questioned whether they should continue paying for acupuncture treatment in the light of the lack of reliable evidence. To r e m e d y the situation, G e r m a n y ' s Federal C o m m i t t e e of Physicians and Health Insurers took a dramatic step and decided to initiate eight high-quality acupuncture trials, which would e x a m i n e four ailments: migraine, tension-type h e a d a c h e , chronic low back pain and knee osteoarthritis. T h e s e trials w e r e to involve m o r e patients than any previous a c u p u n c t u r e trial, w h i c h is w h y they b e c a m e k n o w n as mega-trials. T h e n u m b e r of patients in the trials ranged from 2 0 0 to over 1,000. Each trial divided its patients into three groups: the first group received no acupuncture, the second group received real acupuncture, and the third (placebo) group received sham acupuncture. In terms of sham acupuncture, the researchers did not employ the n e w stage-dagger needles, as they had only just been invented and had not yet been properly assessed. Instead, sham acupuncture took the form of misplaced or superficial needling D u e to their sheer size, these mega-trials have taken m a n y years to conduct. They were completed only recently and the emerging data is still being analysed. Nevertheless, by 2007 the researchers published their initial conclusions from all the mega-trials. T h e y indicate that real acupuncture performs only marginally better than or the same as sham acupuncture. T h e conclusions typically contain the following sort of statement: ' A c u p u n c t u r e w a s no m o r e effective than sham acupuncture in reducing migraine h e a d a c h e s . ' A g a i n , the trend continues - as the trials b e c o m e increasingly rigorous and more reliable, acupuncture increasingly looks as if it is nothing more than a placebo.
Conclusions T h e history of acupuncture research has followed a tortuous path over the last three d e c a d e s , and more research papers will be published in the future, particularly m a k i n g use of the relatively n e w telescopic sham needles and with a fuller evaluation of the G e r m a n mega-trials. H o w e v e r , the research is already fitting together well, with a high level of consistency and agreement. H e n c e , it seems likely that our current
82
TRICK OR TREATMENT?
understanding of acupuncture is fairly close to the truth, and we will conclude this chapter with a s u m m a r y of what we k n o w from the m a s s of research. T h e four key o u t c o m e s are as follows: 1
T h e traditional principles of acupuncture are deeply flawed, as there is no evidence at all to demonstrate the existence of C h ' i or meridians.
2
O v e r the last three d e c a d e s , a h u g e n u m b e r of clinical trials h a v e tested whether or not acupuncture is effective for treating a variety of disorders. S o m e of these trials h a v e implied that acupuncture is effective. Unfortunately, most of them have been without adequate placebo control groups and of poor quality the majority of positive trials are therefore unreliable.
3
By focusing on the increasing n u m b e r of high-quality research p a p e r s , reliable conclusions from systematic reviews m a k e it clear that acupuncture does not work for a whole range of conditions, except as a placebo. H e n c e , if you see acupuncture being advertised by a clinic, then you can assume that it does not really w o r k , except possibly in the treatment of some types of pain and nausea.
4
There are some high-quality trials that support the use of acupuncture for s o m e types of pain and nausea, but there are also high-quality trials that contradict this conclusion. In short, the evidence is neither consistent nor convincing - it is borderline. These four points also apply to variations of acupuncture, such as
acupressure (needles are replaced by pressure applied by fingers or sticks), moxibustion (ground m u g w o r t herb burns above the skin and heats acupuncture p o i n t s ) , and forms of a c u p u n c t u r e involving electricity, laser light or sound vibrations. These therapies are based on the same core principles, and it is simply a question of whether the a c u p u n c t u r e points are p r i c k e d , p r e s s u r i z e d , h e a t e d , electrified,
T H E TRUTH A B O U T ACUPUNCTURE
83
illuminated or oscillated. These more exotic forms of acupuncture have been less rigorously tested than conventional acupuncture, but the overall conclusions are similarly disappointing. In summary, if acupuncture w e r e to be considered in the same way that a new conventional painkilling drug might be tested, then it would have failed to prove itself and would not be allowed into the health market. Nevertheless, acupuncture has grown to b e c o m e a multibillion-pound
worldwide
business
that
exists
largely
outside
mainstream medicine. Acupuncturists would argue that this industry is legitimate, because there is some evidence that acupuncture w o r k s . Critics, on the other hand, would point out that the majority of acupuncturists treat disorders for which there is no respectable evidence whatsoever. And, even in the case of treating pain and nausea, critics would argue that the benefits of acupuncture (if they exist at all) must be relatively small - otherwise these benefits would already have been demonstrated categorically in clinical trials. Moreover, there are conventional painkilling drugs that can achieve levels of pain relief with reasonable reliability, which are vastly cheaper than acupuncture sessions. After all, an acupuncture session costs at least £25 and a full course may run to dozens of sessions. W h e n medical researchers argue that the evidence seems largely to disprove the benefits of acupuncture, the response from acupuncturists often includes five main criticisms. Although superficially persuasive, these criticisms are based on very weak arguments. We shall address t h e m one by one: 1
Acupuncturists point out that we cannot simply ignore those randomized placebo-controlled clinical trials that indicate that acupuncture w o r k s . Of course, such evidence should not be ignored, but it has to be weighed against the evidence that counters it, and we need to decide which side of the argument is more convincing, m u c h as a jury would do in a legal c a s e . So let us weigh up the evidence. Is acupuncture effective for a wide r a n g e of d i s o r d e r s b e y o n d all r e a s o n a b l e d o u b t ? N o . Is acupuncture effective for pain and nausea beyond all reasonable doubt? N o . Is acupuncture effective for pain and nausea on the
84
TRICK OR TREATMENT?
balance of probabilities? T h e jury it still out, but as time has passed and scientific rigour has increased, then the balance of evidence has m o v e d increasingly against acupuncture. F o r e x a m p l e , as this book goes to print, the results have e m e r g e d of a clinical trial involving 640 patients with chronic back pain. According to this piece of research, which was sponsored by the National Institute of Health in A m e r i c a and conducted by Daniel Cherkin,
sham
acupuncture
is j u s t
as
effective
as
real
acupuncture. This supports the view that acupuncture treatment acts as nothing more than a powerful placebo. 2
Practitioners argue that acupuncture, like many alternative therapies, is an individualized, complex treatment and therefore is not suitable for the sort of large-scale testing that is involved in a trial. This argument is based on the misunderstanding that clinical trials necessarily disregard individualization or c o m plexity. T h e truth is that such features can be (and often are) incorporated into the design of clinical trials. Furthermore, most conventional medicine is equally complex and individualized, and yet it has progressed thanks to clinical trials. For instance, a doctor will ask a patient about his or her medical history, a g e , their general health, any recent changes in diet or routine and so on. Having considered all these factors, the doctor will offer a treatment appropriate to that individual patient - that treatment is likely to h a v e been tested in a randomized clinical trial.
3
M a n y acupuncturists claim that the underlying philosophy of their therapy is so at odds with conventional science that the clinical trial is inappropriate for testing its efficacy. But this accusation is irrelevant, because clinical trials have nothing to do with philosophy. Instead, clinical trials are solely concerned with establishing whether or not a treatment w o r k s .
4
Acupuncturists complain that the clinical trial is inappropriate for alternative therapies because the impact of the treatment is very subtle. But if the effect of acupuncture is so subtle that it
T H E TRUTH A B O U T ACUPUNCTURE
85
cannot be detected, then is it really a worthwhile therapy? T h e modern clinical trial is a highly sophisticated, flexible and sensitive approach to assessing the efficacy of any treatment and it is the best w a y of detecting even the most subtle effect. It can measure effects in all sorts of w a y s , ranging from analysing a patient's blood to asking a patient to assess their o w n health. S o m e trials use well-established questionnaires that require patients to report several aspects of their quality of life, such as physical p a i n , emotional problems and vitality. 5
Finally, s o m e acupuncturists point out that real acupuncture m a y perform only as well as sham acupuncture, but w h a t if sham acupuncture offers a genuine medical benefit to patients? We h a v e assumed so far that sham acupuncture is inert, except as a placebo, but is it conceivable that superficial and misplaced needling also s o m e h o w tap into the b o d y ' s meridians? If this turns out to be true, then the entire philosophy of acupuncture falls apart - inserting a needle a n y w h e r e to any depth would have a therapeutic benefit, which seems highly unlikely. A l s o , the development of the telescopic needle sidesteps this question because it d o e s not puncture the skin, so it cannot possibly tap into any meridians. Acupuncturists might counter by arguing that telescopic needles also offer therapeutic benefit because they apply pressure to the skin, but if this were the case then we would also receive benefits from a h a n d s h a k e , a tap on the back or scratching an ear. Alternatively, such pressure on the skin might sometimes detrimentally influence the flow of C h ' i , so such bodily contact might m a k e us ill.
In short, n o n e of these criticisms stands up to proper scrutiny. T h e y are the sort of flimsy arguments that one might expect from practitioners w h o instinctively want to protect a therapy in which they have both a professional and an emotional investment. Such acupuncturists are unwilling to accept that the clinical trial is undoubtedly the best m e t h o d available for minimizing bias. Although never perfect, the clinical trial allows us to get as close to the truth as we possibly can.
86
TRICK OR TREATMENT?
In fact, it is important to r e m e m b e r that the clinical trial is so effective at minimizing bias that it is also a vital tool in researching conventional medicine. This is a point that was well m a d e by the British Nobel Prize-winning scientist Sir Peter M e d a w a r : Exaggerated claims for the efficacy of a medicament are very seldom the consequence of any intention to deceive; they are usually the outcome of a kindly conspiracy in which everybody has the very best intentions. The patient wants to get well, his physician wants to have made him better, and the pharmaceutical company would have liked to have put it into the physician's power to have made him so. The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will. Although this chapter demonstrates that acupuncture is very likely to be acting as nothing more than a p l a c e b o , we cannot end it without raising one issue that might rescue the role of acupuncture within a modern healthcare system. We h a v e already seen that the placebo effect can be a very powerful and positive influence in healthcare, and acupuncture seems to be very good at eliciting a placebo response. H e n c e , can acupuncturists justify their existence by practising placebo medicine and helping patients with an essentially fake treatment? For e x a m p l e , we explained that the G e r m a n mega-trials divided patients into three groups: one received real acupuncture, one received sham acupuncture, and one received no acupuncture at all. In general, the results showed that real acupuncture significantly reduced pain in about half of patients and sham acupuncture delivered roughly the same level of benefit, while the third group of patients showed significantly
less
improvement.
The
fact
that
real
and
sham
acupuncture are roughly as effective as each other implies that real acupuncture merely exploits the placebo effect - but does this matter as long as patients are deriving benefit? In other w o r d s , does it matter that the treatment is fake, as long as the benefit is real? A treatment that relies so heavily on the placebo effect is essentially a bogus treatment, akin to M e s m e r ' s magnetized water and P e r k i n s ' tractors. Acupuncture works only because the patients have faith in the
T H E TRUTH A B O U T ACUPUNCTURE
87
treatment, but if the latest research w e r e to be more strongly p r o m o t e d , then some patients w o u l d lose their confidence in acupuncture and the placebo benefits would largely melt away. S o m e people might therefore argue that there should be a conspiracy of silence so that the mystique and p o w e r of acupuncture is maintained, which in turn would m e a n that patients could continue to benefit from needling. Others might feel that misleading patients is fundamentally wrong and that administering placebo treatments is unethical. T h e issue of whether or not placebo therapies are acceptable will be relevant to some other forms of alternative medicine, so this issue will be fully addressed in the final chapter. In the m e a n t i m e , the main question is:
w h i c h of the other major alternative therapies are
genuinely effective, and w h i c h are merely placebos?
88
TRICK OR TREATMENT?
The Truth About Homeopathy 'Truth is tough. It will not break, like a bubble, at a touch; nay, you may kick it about all day, like a football, and it will be round and full at evening.' Oliver Wendell Holmes, Sr
Homeopathy (or Homoeopathy)
A system for treating illness based on the premise that like cures like. The homeopath treats symptoms by administering minute or non-existent doses of a substance which in large amounts produces the same symptoms in healthy individuals. Homeopaths focus on treating patients as individuals and claim to be able to treat virtually any ailment, from colds to heart disease.
IN
RECENT DECADES
HOMEOPATHY HAS
BECOME
ONE OF THE FASTEST-
g r o w i n g forms of alternative m e d i c i n e , particularly in E u r o p e . T h e proportion of the French population using h o m e o p a t h y increased from 16 per cent to 36 per cent between 1982 and 1992, while in B e l g i u m over half the population regularly relies on homeopathic r e m e d i e s . T h i s rise i n d e m a n d h a s e n c o u r a g e d m o r e p e o p l e t o b e c o m e practitioners - k n o w n as h o m e o p a t h s - and it has even convinced some conventional doctors to study the subject and offer h o m e o p a t h i c treatm e n t s . T h e U K - b a s e d Faculty of H o m e o p a t h y already has over 1,400 doctors on its register, but the greatest n u m b e r of practitioners is in India, where there are 300,000 qualified h o m e o p a t h s , 182 colleges and 300 homeopathic hospitals. And while A m e r i c a has far fewer h o m e opaths than India, the profits to be m a d e are much greater. Annual sales in the United States increased fivefold from $ 3 0 0 million in 1987 to $1.5 billion in 2 0 0 0 . With so many practitioners and so m u c h commercial success, it would be reasonable to assume that homeopathy must be effective. After all, w h y else would millions of people - educated and uneducated, rich and poor, in the East and the West - rely on it? Yet the medical and scientific establishment has generally viewed homeopathy with a great deal of scepticism, and its remedies have been at the centre of a long-running and often heated debate. This chapter will look at the evidence and reveal whether homeopathy is a medical marvel or whether the critics are correct w h e n they label it a quack medicine.
The origins of homeopathy Unlike acupuncture, h o m e o p a t h y ' s origins are not shrouded in the mists of time, but can be traced back to the work of a G e r m a n
T H E TRUTH A B O U T HOMEOPATHY
93
physician called Samuel H a h n e m a n n at the end of the eighteenth century. Having studied medicine in Leipzig, Vienna and Erlangen, Hahnemann
earned a reputation
as
one
of E u r o p e ' s
foremost
intellectuals. He published widely on both medicine and chemistry, and used his k n o w l e d g e of English, French, Italian, G r e e k , Latin, A r a b i c , Syriac, Chaldaic and H e b r e w to translate n u m e r o u s scholarly treatises. He seemed set for a distinguished medical career, but during the 1780s he began to question the conventional practices of the day. For instance, he rarely bled his patients, even though his colleagues strongly advocated bloodletting. Moreover, he was an outspoken critic of those responsible for treating the Holy R o m a n E m p e r o r Leopold of Austria, w h o was bled four times in the twenty-four hours immediately prior to his death in 1792. According to H a h n e m a n n , L e o p o l d ' s high fever and abdominal distension did not require such a risky treatment. Of course, we n o w k n o w that bloodletting is indeed a d a n g e r o u s intervention. T h e imperial court physicians, however, responded by calling H a h n e m a n n a murderer for depriving his o w n patients of what they d e e m e d to be a vital medical procedure. H a h n e m a n n was a decent m a n , w h o c o m b i n e d intelligence with integrity. He gradually realized that his medical colleagues knew very little about h o w to diagnose their patients accurately, and worse still these doctors knew even less about the impact of their treatments, which meant that they probably did more harm than g o o d . Not surprisingly, H a h n e m a n n eventually felt unable to continue practising this sort of medicine: My sense of duty would not easily allow me to treat the unknown pathological state of my suffering brethren with these unknown medicines. The thought of becoming in this way a murderer or malefactor towards the life of my fellow human beings was most terrible to me, so terrible and disturbing that I wholly gave up my practice in the first years of my married life and occupied myself solely with chemistry and writing.
94
TRICK OR TREATMENT?
In
1790,
away
from
medicine,
having
moved
all c o n v e n t i o n a l Hahnemann
was
inspired to develop his o w n revolutionary medicine.
school
His
first
of step
towards inventing homeopathy took
place
when
he began
experimenting on himself with the drug Cinchona, which is derived from the bark of a Peruvian tree. C i n c h o n a contains quinine and was being used
successfully
treatment
of
in
the
malaria,
but
Samuel Hahnemann
H a h n e m a n n c o n s u m e d it when he was healthy, perhaps in the hope that it might act as a general tonic for maintaining good health. To his surprise, however, his health began to deteriorate and he developed the sort of s y m p t o m s usually associated with malaria. In other w o r d s , here was a substance that w a s normally used for curing the fevers, shivering and sweating suffered by a malaria patient, which w a s n o w apparently generating the same s y m p t o m s in a healthy person. He experimented with other treatments and obtained the same sort of results: substances used to treat particular s y m p t o m s in an unhealthy person seemed to generate those same s y m p t o m s w h e n given to a healthy person. By reversing the logic, he proposed a universal principle, namely 'that which can produce a set of s y m p t o m s in a healthy individual, can treat a sick individual w h o is manifesting a similar set of s y m p t o m s ' . In 1796 he published an account of his Law of Similars, but so far he had gone only halfway towards inventing homeopathy. H a h n e m a n n went on to propose that he could improve the effect of his
' l i k e c u r e s l i k e ' r e m e d i e s b y diluting t h e m . A c c o r d i n g t o
H a h n e m a n n , and for reasons that continue to remain mysterious, diluting a remedy increased its p o w e r to cure, while reducing its potential
to
cause
side-effects.
His
assumption
bears
T H E TRUTH A B O U T HOMEOPATHY
some
95
resemblance to the 'hair of the dog that bit y o u ' d i c t u m , i n a s m u c h as a little of what has h a r m e d s o m e o n e can supposedly u n d o the h a r m . T h e expression has its origins in the belief that a bite from a rabid dog could be treated by placing some of the d o g ' s hairs in the w o u n d , but n o w a d a y s 'the hair of the d o g ' is used to suggest that a small alcoholic drink can cure a hangover. Moreover, while carrying his remedies on board a horse-drawn carriage, H a h n e m a n n m a d e another breakthrough. He believed that the vigorous shaking of the vehicle had further increased the so-called potency of his h o m e o p a t h i c r e m e d i e s , as a result of which he began to r e c o m m e n d that shaking (or succussion)
should form part of the
dilution process. T h e combination of dilution and shaking is k n o w n as potentization. Over
the
next
few
years,
Hahnemann
identified
various
homeopathic remedies by conducting experiments k n o w n as provings, from the G e r m a n word priifen, m e a n i n g to e x a m i n e or test. This w o u l d involve giving daily doses of a homeopathic r e m e d y to several healthy people and then asking t h e m to keep a detailed diary of any s y m p t o m s that might emerge over the course of a few w e e k s . A compilation of their diaries was then used to identify the range of s y m p t o m s suffered by a healthy person taking the remedy - H a h n e m a n n then argued that the identical r e m e d y given to a sick patient could relieve those same symptoms. In 1807 H a h n e m a n n coined the word Homdopathie, from the G r e e k homoios and pathos, m e a n i n g similar suffering. T h e n in published
Organon der rationellen Heilkunde
(Organon
1810 he
of the Medical
Art), his first major treatise on the subject of homeopathy, which w a s followed in the next decade by Materia Medica Pura, six volumes that detailed the s y m p t o m s cured by sixty-seven homeopathic r e m e d i e s . H a h n e m a n n had given h o m e o p a t h y a firm foundation, and the w a y that it is practised has hardly changed over the last t w o centuries. According to Jay W. Shelton, w h o has written extensively on the subject, ' H a h n e m a n n and his writings are held in almost religious reverence by most h o m e o p a t h s . '
96
TRICK OR TREATMENT?
The gospel according to Hahnemann H a h n e m a n n was adamant that h o m e o p a t h y was distinct from herbal m e d i c i n e , and m o d e r n h o m e o p a t h s still maintain a separate identity and refuse to be labelled herbalists. O n e of the m a i n reasons for this is that homeopathic remedies are not solely based on plants. T h e y can also be based on animal sources, which sometimes m e a n s the w h o l e animal (e.g. ground h o n e y b e e ) , and sometimes just animal secretions (e.g. snake poison, wolf m i l k ) . Other remedies are based on mineral sources, ranging from salt to gold, while so-called nosode sources are based on diseased material or causative agents, such as bacteria, p u s , vomit,
tumours,
faeces
and
warts.
Since
Hahnemann's
era,
h o m e o p a t h s have also relied upon an additional set of sources labelled imponderables, which covers non-material p h e n o m e n a such as X-rays and magnetic fields. There is something innately comforting about the idea of herbal m e d i c i n e s , which conjures up images of leaves, petals and roots. H o m e o p a t h i c r e m e d i e s , by contrast, can sound rather disturbing. In the nineteenth century, for instance, a h o m e o p a t h describes basing a remedy on ' p u s from an itch pustule of a y o u n g and otherwise healthy N e g r o , w h o had been infected [with s c a b i e s ] ' . Other homeopathic remedies require crushing live b e d b u g s , operating on live eels and injecting a scorpion in its rectum. Another reason why h o m e o p a t h y is absolutely distinct from herbal m e d i c i n e , even if the homeopathic r e m e d y is based on plants, is H a h n e m a n n ' s e m p h a s i s on dilution. If a plant is to be used as the basis of a homeopathic remedy, then the preparation process begins by allowing it to sit in a sealed jar of solvent, which then dissolves some of the plant's m o l e c u l e s . T h e solvent can be either water or alcohol, but for ease of explanation we will assume that it is water for the remainder of this chapter. After several weeks the solid material is r e m o v e d - the remaining water with its dissolved ingredients is called the
mother
tincture.
T h e mother tincture is then diluted, which might involve one part of it being dissolved in nine parts water, thereby diluting it by a factor of ten. This is called a IX remedy, the X being the R o m a n numeral
T H E TRUTH A B O U T HOMEOPATHY
97
for 10. After the dilution, the mixture is vigorously shaken, which completes the potentization process. Taking one part of the IX remedy, dissolving it in nine parts water and shaking again leads to a 2X remedy. Further dilution and potentization leads to 3 X , 4 X , 5X and even weaker solutions - r e m e m b e r , H a h n e m a n n believed that weaker solutions led to stronger r e m e d i e s . Herbal medicine, by contrast, follows the more c o m m o n s e n s e rule that more concentrated doses lead to stronger r e m e d i e s . T h e resulting h o m e o p a t h i c solution, whether it is I X , 10X or even more dilute, can then be directly administered to a patient as a remedy. Alternatively, drops of the solution can be added to an ointment, tablets or some other appropriate form of delivery. For e x a m p l e , one drop might be used to wet a dozen sugar tablets, which would transform them into a dozen homeopathic pills. At this point, it is important to appreciate the extent of the dilution undergone during the preparation of homeopathic r e m e d i e s . A 4X remedy, for instance, m e a n s that the mother tincture w a s diluted by a factor of 10 ( I X ) , then again by a factor of 10 ( 2 X ) , then again by a factor of 10 ( 3 X ) , and then again by a factor of 10 ( 4 X ) . This leads to dilution by a factor o f l O x l O x l O x 10, which is equal to 10,000. Although this is already a high degree of dilution, homeopathic r e m e dies generally involve e v e n m o r e e x t r e m e dilution. Instead of dissolving in factors of 10, homeopathic pharmacists will usually dissolve one part of the mother tincture in 99 parts of water, thereby diluting it by a factor of 100. This is called a 1C remedy, C being the R o m a n numeral for 100. Repeatedly dissolving by a factor of 100 leads to 2 C , 3 C , 4C and eventually to ultra-dilute solutions. For e x a m p l e , homeopathic strengths of 30C are c o m m o n , which m e a n s that the original ingredient has been diluted 30 times by a factor of 100 each t i m e . Therefore, the original substance has been diluted by a
factor
of
1,000,000,000,000,000,000,000,000,000,000,000,000,
000,000,000,000,000,000,000,000. This string of noughts might not mean m u c h , but bear in mind that one gram of the mother tincture contains less than 1,000,000,000,000,000,000,000,000 m o l e c u l e s . As indicated by the n u m b e r of n o u g h t s , the degree of dilution is vastly bigger than the n u m b e r of molecules in the mother tincture, which
98
TRICK OR TREATMENT?
Figure 2 Homeopathic remedies are prepared by repeated dilution,
with vigorous shaking between stages.
Test tube A contains the initial solution, called the mother tincture, which in this case has 100 molecules of the active ingredient. A sample from test tube A is then diluted by a factor of ten (IX), which leads to test tube B, which contains only 10 molecules in a so-called IX dilution. Next, a sample from test tube B is diluted by a factor of ten again (2X), which leads to test tube C, which contains only 1 molecule. Finally, a sample from test tube C is diluted by a factor of ten for a third time (3X), which leads to test tube D, which is very unlikely to contain any molecules of the active ingredient. Test tube D, devoid of any active ingredient, is then used to make homeopathic remedies.
In practice, the number of molecules in the mother tincture will be much
greater, but the number of dilutions and the degree of dilution is generally more extreme, so the end result is typically the same - no molecules in the remedy.
m e a n s that there are simply not e n o u g h molecules to go r o u n d . T h e bottom line is that this level of dilution is so e x t r e m e that the resulting solution is unlikely to contain a single molecule of the original ingredient. In fact, the c h a n c e of h a v i n g one m o l e c u l e of the active ingredient in the final 3 0 C remedy is one in a billion billion billion billion. In other w o r d s , a 3 0 C h o m e o p a t h i c remedy is almost certain to contain nothing m o r e than water. This point is graphically explained in Figure 2. A g a i n , this underlines the difference between herbal and homeopathic remedies - herbal remedies will always have at least a small a m o u n t of active ingredient, whereas h o m e o p a t h i c remedies usually contain no active ingredient whatsoever.
THE TRUTH A B O U T HOMEOPATHY
99
Materials that will not dissolve in water, such as granite, are ground d o w n and then one part of the resulting p o w d e r is mixed with 99 parts lactose (a form of sugar), which is then ground again to create a 1C composition. O n e part of the resulting p o w d e r is mixed with 99 parts lactose to create a 2C composition, and so on. If this process is repeated 30 times, then the resulting p o w d e r can be c o m p a c t e d into 3 0 C tablets. Alternatively, at any stage the p o w d e r might be dissolved in water and the r e m e d y can be repeatedly diluted as described previously. In either c a s e , the resulting 30C r e m e d y is, again, almost guaranteed to contain no atoms or molecules of the original active granite ingredient. As if all this w a s not sufficiently mysterious, some homeopathic pharmacies stock 100,000C remedies, which means that the manufacturers are taking 30C r e m e d i e s , already devoid of any active ingredient, and then diluting them by a factor of 100 another 99,970 t i m e s . Because of the time required to m a k e 100,000 dilutions, each o n e followed by a vigorous shaking, such remedies can cost more than £1,000. F r o m a scientific perspective, it is impossible to explain h o w a remedy that is devoid of any active ingredient can have any conceivable effect on any medical condition, apart from the obvious placebo effect. H o m e o p a t h s would argue that the remedy has s o m e m e m o r y of the original ingredient, which s o m e h o w influences the body, but this m a k e s no scientific sense. Nevertheless, h o m e o p a t h s still claim that their remedies are effective for a whole range of conditions, from temporary problems ( c o u g h s , diarrhoea and headaches) to more chronic conditions (arthritis, diabetes and a s t h m a ) , and from minor ailments (bruises and colds) to more serious conditions (cancer and Parkinson's disease). Although we h a v e listed various diseases, it is important to point out that H a h n e m a n n and his descendants do not see themselves as treating diseases in a conventional sense. Instead they focus on the individual s y m p t o m s and the characteristics of the patients. This is best illustrated by describing how a h o m e o p a t h typically deals with a case. T h e h o m e o p a t h starts by conducting a detailed interview with the patient, asking about both physical and psychological s y m p t o m s . This
100
TRICK OR TREATMENT?
will result in several pages of notes detailing every s y m p t o m , including where each one occurs in the body, w h e n they arise and any activities that affect these s y m p t o m s . For e x a m p l e , even if the chief complaint is earache, the notes will include meticulous descriptions of everything from the patient's bunions to any recent constipation. H o m e o p a t h y is a highly individualized therapy, so the consultation m a y even ask about the patient's personality, emotional wellbeing, apparently trivial matters from their past and preferences for food, colours and smells. This w h o l e interview process usually lasts for m o r e than an hour and the o u t c o m e is a complete analysis of the patient's s y m p t o m s . As the ultimate goal is to find a homeopathic r e m e d y that best fits all the s y m p t o m s that h a v e been described, the next stage is to consult the Materia Medica, the encyclopaedia that lists the remedies and what they should be used for. Although H a h n e m a n n identified just a few dozen remedies in his early writings, the h o m e o p a t h William Boericke included over 600 in his Materia Medica in Homeopathic
Pharmacopoeia
of the
United
1 9 0 1 , and today The
States
recognizes
over
1,000. Trawling through all these potential remedies is all the m o r e complicated because each remedy treats n u m e r o u s s y m p t o m s and so its entry can run to more than a p a g e . For instance, Figure 3 shows the entry for Aceticum acidum, better k n o w n as acetic acid or the chemical associated with vinegar. Ideally the homeopath is looking for the simillimum, which is to say the r e m e d y that offers a perfect match with the patient's s y m p t o m s . In order to find this optimal remedy, the h o m e o p a t h might refer to a repertory, which is organized according to each s y m p t o m followed by the remedies associated with it (as opposed to a Materia Medica, which is organized according to each remedy followed by its associated s y m p t o m s ) . Poring through a repertory can still be a major task, so the h o m e o p a t h will tend to focus on very special and peculiar s y m p toms to help narrow the search. For e x a m p l e , according to Boericke's Materia Medica, ' F a c e : distortion of m o u t h , trembling of j a w , facial paralysis; more left side' coupled with 'Stool: bloody, black, and offensive. G e l a t i n o u s , yellowish
green;
semi-fluid, with urinary
suppression' means that C a d m i u m sulphate is the ideal remedy.
T H E TRUTH A B O U T HOMEOPATHY
101
Figure 3 This is the entry for the homeopathic remedy Aceticum acidum, taken from William Boericke's Materia
Medica.
It offers
numerous curious statements about Aceticum
acidum,
such
as
'Counteracts sausage poisoning' and recommending its use for people worried about business affairs.
Aceticum Acidum Glacial Acetic Acid (Acetic Acid) This drug produces a condition of profound anaemia, with some dropsical symptoms, great debility, frequent fainting, dyspnoea, weak heart, vomiting, profuse urination and sweat. Haemorrhage from any part. Especially indicated in pale, lean persons, with lax, flabby muscles. Wasting and debility. Acetic acid has the power to liquefy albuminous and fibrinous deposits. Epithelial cancer, internally and locally (W Owens). Sycosis with nodules and formations in the joints. Hard chancre. The IX solution will soften and cause formation of pus. Mind
Irritable, worried about business affairs.
Head
Nervous headache, from abuse of narcotics. Blood rushes to head with delirium. Temporal vessels distended. Pain across root of tongue.
Face
Pale, waxen, emaciated. Eyes sunken, surrounded by dark rings. Bright red. Sweaty. Epithelioma of lip. Cheeks hot and flushed. Aching in left jaw-point.
Stomach
Salivation. Fermentation in stomach. Intense burning thirst. Cold drinks distress. Vomits after every kind of food. Epi-gastric tenderness. Burning pain as of an ulcer. Cancer of stomach. Sour belching and vomiting. Burning waterbrash and profuse salivation. Hyperchlorhydria and gastralgia. Violent burning pain in stomach and chest, followed by coldness of skin and cold sweat on forehead. Stomach feels as if she had taken a lot of vinegar.
102
TRICK OR TREATMENT?
Abdomen
Feels as if abdomen was sinking in. Frequent watery stools, worse in morning. Tympanitic. Ascites. Haemorrhage from bowels.
Urine
Large quantities of pale urine. Diabetes, with great thirst and debility (Phos ac).
Female
Excessive catamenia. Haemorrhages after labor. Nausea of pregnancy. Breasts painfully enlarged, distended with milk. Milk impoverished, bluish, transparent, sour. Anaemia of nursing mothers.
Respiratory
Hoarse, hissing respiration; difficult breathing; cough when inhaling. Membranous croup. Irritation of trachea and bronchial tubes. False membrane in throat. Profuse bronchorrhoea. Putrid sore throat (gargle).
Back
Pain in back, relieved only by lying on abdomen.
Extremities
Emaciation. (Edema of feet and legs.
Skin
Pale, waxen, oedematous. Burning, dry, hot skin, or bathed in profuse sweat. Diminished sensibility of the surface of body. Useful after stings, bites, etc. Varicose swellings. Scurvy; anasarca. Bruises; sprains.
Fever
Hectic, with drenching night-sweats. Red spot on left cheek. No thirst in fever. Ebullitions. Sweat profuse, cold.
Relationship Acetic acid is antidotal to all anaesthetic vapors. Counteracts sausage poisoning. Compare
Ammon acet (Profuse saccharine urine, patient is bathed in sweat). Benzoin oderiferum—Spice-wood (night sweats). Ars; China; Digitalis; Liatris (General anasarca in heart and kidney disease, dropsy, and chronic diarrhoea).
Dose
Third to thirtieth potency. Not to be repeated too often, except in croup.
T H E TRUTH A B O U T HOMEOPATHY
103
Finding the correct r e m e d y is such a complicated and subtle task that a patient w h o visited different h o m e o p a t h s and w h o underwent different interviews w o u l d be likely to receive different r e m e d i e s . In fact, the process of finding the correct r e m e d y can vary so m u c h that it has led to the e m e r g e n c e of distinct schools of homeopathy. For e x a m p l e , clinical homeopathy simplifies matters by focusing only on the patient's main s y m p t o m and ignoring the more tangential aspects that would emerge during the usual h o m e o p a t h ' s interview. Similarly, combination
homeopathy
is
interested
only
in
the
patient's
main
s y m p t o m , but it relies on mixtures of different remedies that all share the ability to treat this one outstanding s y m p t o m . In other w o r d s , a patient with migraine w o u l d receive a homeopathic mixture of all the remedies that include headache as one of the s y m p t o m s that they cure. Another way to prescribe is according to the doctrine of signatures, which places less e m p h a s i s on the s y m p t o m s in the Materia Medica and instead looks for a clue, or signature, that indicates that a particular remedy is the one that should be adopted. Therefore a walnut-based remedy would be appropriate for various mind-related disorders, such as stress, because the walnut resembles a brain. With so many approaches and so many possible r e m e d i e s , some homeopaths employ specific and peculiar techniques for checking that they have found the appropriate treatment. This can include d o w s i n g , whereby a p e n d u l u m is held above a shortlist of possible r e m e d i e s . T h e direction of swinging should indicate the correct remedy, yet a scientific trial conducted in 2002 showed no evidence for the p o w e r of homeopathic d o w s i n g . Six h o m e o p a t h s were given twenty-six pairs of bottles; one bottle in each pair contained Bryonia r e m e d y and the other contained a p l a c e b o , and the challenge was to use d o w s i n g to identify the genuine remedy. Although the h o m e o p a t h s generally felt that they were selecting with a high degree of confidence, they were successful only 75 times out of 156 trials, which is a success rate of just under 50 per cent: roughly what one would expect from g u e s s w o r k . All this ritual - from extreme dilutions to vigorous shaking, from prolonged provings to dubious d o w s i n g - is performed with the ultimate goal of trying to restore a patient's vital force to its usual, healthy balance. H a h n e m a n n proposed that this vital force, something akin to
104
TRICK OR TREATMENT?
the spirit, permeated the body and entirely determined a person's wellbeing.
Many
modern homeopaths
still
believe
i n the
crucial
significance of the vital force, which in turn m e a n s that they tend to reject many of the principles of conventional m e d i c i n e , such as the role of bacteria as agents of disease. For e x a m p l e , a h o m e o p a t h w o u l d treat a patient with an ear problem by noting every single mental and physical s y m p t o m and then prescribing the most appropriate r e m e d y according to the Materia Medica; the goal would be to rebalance the patient's vital force. By contrast, a conventional doctor would focus on the patient's main s y m p t o m s , perhaps diagnose a bacterial ear infection and then prescribe antibiotics to kill the bacteria. Not surprisingly, m o d e r n science struggles to accept homeopathy. After all, there is no logical reason w h y like should be guaranteed to cure like; there is no k n o w n m e c h a n i s m that would allow such ultraw e a k dilutions (devoid of any ingredient) to impact on our body; and there is no evidence whatsoever to support the existence of a vital force. H o w e v e r , the sheer oddity of h o m e o p a t h y ' s philosophy and practice does not necessarily mean that this approach to medicine should be rejected, because the critical test is not h o w bizarre it is, but whether or not it is effective. This can best be decided via the ordeal of the clinical trial, that tried and trusted tool of evidence-based m e d i c i n e , which is capable of separating genuine medicine from quackery.
The rise and fall and rise of homeopathy H o m e o p a t h y spread rapidly through Europe during the first half of the nineteenth century, so m u c h so that H a h n e m a n n ' s philosophy b e c a m e well established during his o w n lifetime. T h e idea that 'like cures like' and the belief that diseases were ' d e r a n g e m e n t s of the spirit-like p o w e r that animates the h u m a n b o d y ' sounded similar to some elements of the
still highly respected G r e e k philosophy of m e d i c i n e , so
homeopathy was greeted with enthusiasm. Moreover, H a h n e m a n n ' s ideas were emerging before scientists had firmly established the g e r m theory of disease or the atomic theory of matter, so the vital force and ultra-weak dilutions did not sound quite so strange as they do today. Signs of H a h n e m a n n ' s growing influence ranged from opening the
T H E TRUTH A B O U T HOMEOPATHY
105
world's first homeopathic hospital in Leipzig in 1833 to the use of homeopathy to treat N a p o l e o n ' s pubic lice. H o m e o p a t h y b e c a m e particularly fashionable in Paris in the 1830s, because H a h n e m a n n set up h o m e in the city after marrying a beautiful Parisian socialite named Marie Melanie d'Herville-Gohier - he was eighty years old and she was in her early thirties. With her patronage and his reputation, they were able to run a lucrative practice for the wealthy elite, with M r s H a h n e m a n n assisting her husband in the afternoon and running her o w n clinic for the poor in the m o r n i n g . Elsewhere in E u r o p e , H a h n e m a n n ' s disciples spread the gospel of homeopathy with their m a s t e r ' s voice ringing in their ears: ' H e w h o does not walk exactly on the same line with m e , w h o diverges, if it be but the breadth of a straw to the left or right, is a traitor and I will have nothing to do with h i m . ' Certainly Dr Frederick Q u i n , w h o had studied with H a h n e m a n n in Paris, was no such traitor, for he established homeopathy in L o n d o n in 1827 strictly according to H a h n e m a n n ' s principles. It
soon
became
highly
p o p u l a r a m o n g the
British
aristocracy, and within half a century it was being practised across the country, with large homeopathic hospitals being founded in L o n d o n , Bristol, B i r m i n g h a m , Liverpool and Glasgow. Although w e l c o m e d by m a n y doctors and patients, this rapid growth was not without controversy. W h e n William H e n d e r s o n , Professor of General Pathology at Edinburgh University, began to support homeopathy in the 1840s, a colleague wrote: ' T h e consternation manifested by the Medical Faculty in the University and by the College of Physicians was such as might be exhibited in ecclesiastical circles if the Professor of Divinity were to a n n o u n c e that he had become a Mohammedan.' At roughly the same t i m e , homeopathy was also establishing itself on the other side of the Atlantic. Dr Hans Burch G r a m , a Bostonian of Danish
descent,
learned
about
homeopathy
during
a
visit
to
C o p e n h a g e n and then brought the idea back to America in 1825. Just as had happened in Britain, homeopathy gained both ardent supporters and fervent critics. T h e result w a s that there were 2,500 practitioners and six homeopathic colleges by the outbreak of the American Civil War, but h o m e o p a t h s w e r e still largely denied the opportunity to serve
106
TRICK OR TREATMENT?
in the army. A professor at the H o m e o p a t h i c Medical College of Missouri argued that this infringed a soldier's right to receive the medical care of his o w n choice: Are personal rights abrogated by the Constitution in time of war? Has a soldier no right to think for himself, and to ask for that relief from suffering and death which his experience for years has taught him is best? Has Congress a right to establish a privileged order in medicine in violation of the spirit and genius of our government? In order to deal with their critics, h o m e o p a t h s would often point to the successes they had achieved in dealing with major e p i d e m i c s . As early as 1800, H a h n e m a n n himself had used ultra-dilute Belladonna to combat scarlet fever; then in 1813 he used h o m e o p a t h y to treat an epidemic of typhus spread by N a p o l e o n ' s soldiers after their invasion of Russia; and in 1831 homeopathic remedies such as C a m p h o r , C u p r u m and Veratrum were apparently successful in central E u r o p e in tackling outbreaks of cholera, a disease that conventional medicine was unable to treat. This success was repeated during a cholera epidemic in L o n d o n in 1854, when patients at the L o n d o n H o m o e o p a t h i c Hospital had a survival rate of 84 per cent, c o m p a r e d to just 47 per cent for patients receiving more conventional treatment at the nearby M i d d l e s e x Hospital.
Many
homeopaths
therefore
argued
that
this
was
strong evidence in support of homeopathy, because it w a s possible to construe the results from these t w o hospitals as the o u t c o m e of an
informal
trial.
The
percentages
allow
us
to
compare
the success rates of two treatments on t w o groups of patients with the same illness, and homeopathic remedies clearly did better than conventional m e d i c i n e . H o w e v e r , critics later pointed out three major reasons w h y these percentages did not necessarily mean that h o m e o p a t h y was effective. First, the patients at the t w o hospitals had the same illness, but that does not necessarily mean that the t w o hospitals were c o m p e t i n g on a level playing field. It could b e , for instance, that the patients w h o attended the London H o m o e o p a t h i c Hospital were wealthier, which
T H E TRUTH A B O U T HOMEOPATHY
107
would mean that they were in a better state of health before catching cholera and were better fed and cared for after leaving hospital - all of this, rather than the homeopathic treatment itself, might account for the higher success rate. Second, as well as differing in the treatment that they offered, the t w o hospitals m a y have differed in other important w a y s . F o r instance, the L o n d o n H o m o e o p a t h i c Hospital might have had a higher standard of hygiene than the M i d d l e s e x Hospital, which could easily explain its superior survival rate. After all, we are dealing with an infectious disease, so clean w a r d s , uncontaminated food and safe water were of the utmost importance. T h i r d , perhaps the higher survival rate at the L o n d o n H o m o e o p a t h i c Hospital was not indicative of the success of homeopathy, but rather it pointed to the failure of conventional m e d i c i n e . Indeed, medical historians suspect that patients w h o received no medical care w o u l d probably have fared better than those w h o received the conventional medications given at the t i m e . This might s e e m surprising, but the 1850s still belonged to the era of so-called 'heroic m e d i c i n e ' , w h e n doctors probably did m o r e h a r m than good. 'Heroic m e d i c i n e ' w a s a term invented in the twentieth century to describe the aggressive practices that dominated healthcare up until the mid-nineteenth century. Patients had to endure bloodletting, intestinal purging, vomiting, sweating and blistering, which generally stressed an already w e a k e n e d body. On top of this, patients w o u l d receive large doses of medications, such as mercury and arsenic, which scientists n o w k n o w to be highly toxic. T h e extreme bloodletting suffered by George Washington, as described in Chapter 1, is a p r i m e e x a m p l e of heroic medicine and its harmful impact on a patient. T h e label 'heroic m e d i c i n e ' reflected the role played by the supposedly heroic doctor, but a n y o n e w h o survived the treatment w a s the real h e r o . T h e richest patients were the most heroic of all, because they endured the most severe treatments. This observation was m a d e as early as 1622, when a Florentine physician, Antonio Durazzini, reported on the recovery rates from a fever that was spreading through the region: ' M o r e of those w h o are able to seek medical advice and treatment die than of the poor.' It w a s during this period that Latanzio Magiotti, the
108
TRICK OR TREATMENT?
Grand D u k e of Florence's o w n doctor, said, ' M o s t Serene H i g h n e s s , I take the m o n e y not for my services as a doctor but as a guard, to prevent some young m a n w h o believes everything he reads in books from coming along and stuffing something d o w n the patients which kills them.' A l t h o u g h the desperate, wealthy and sick continued to rely on doctors, m a n y onlookers openly criticized their practices. Benjamin Franklin c o m m e n t e d ,
'All drug doctors are q u a c k s , ' while the
philosopher Voltaire w r o t e , 'Doctors are m e n w h o prescribe m e d i c i n e s of which they k n o w little, to cure diseases of which they k n o w less, in h u m a n beings of w h o m they k n o w nothing.' He advised that a good physician was one w h o a m u s e d his patients while nature cured the disease. These concerns about medicine were also reflected by several dramatists, including Shakespeare, w h o in Timon of Athens has T i m o n advise: 'Trust not the physician; His antidotes are poisons.' Similarly, in Le Malade imaginaire, Moliere wrote: 'Nearly all m e n die of their remedies and not of their illnesses.' H e n c e , if no treatment at all would have been better than conventional heroic medicine for cholera patients, then modern sceptics are not surprised that h o m e o p a t h y was also better than conventional heroic medicine. After all, the sceptics feel that the homeopathic remedies were so diluted that taking them was the equivalent to having no treatment. In short, we can conclude two things about a patient seeking treatment before the twentieth century. First, the patient w o u l d h a v e been better off opting for no treatment rather than heroic medicine. S e c o n d , the patient would have been better off opting for h o m e o p a t h y rather than for heroic medicine. T h e important question, however, w a s whether h o m e o p a t h y was any better than a lack of treatment? T h o s e w h o supported h o m e o p a t h y were convinced by their o w n experience that it w a s genuinely effective, whereas sceptics argued that such dilute remedies could not possibly benefit the patient. The
a r g u m e n t s c o n t i n u e d t h r o u g h o u t the n i n e t e e n t h c e n t u r y ;
and despite the initially positive response from the aristocracy and significant sections of the medical c o m m u n i t y , there was a gradual swing against H a h n e m a n n ' s ideas as each decade passed. For e x a m p l e ,
THE TRUTH A B O U T HOMEOPATHY
109
the A m e r i c a n physician and writer Oliver Wendell H o l m e s accepted that conventional medicine had failed in the past ('If all the medicine in the world were thrown into the sea, it would be bad for the fish and good for h u m a n i t y ' ) , but he was not prepared to tolerate homeopathy as the
way
forward.
He
called
homeopathy 'a m a n g l e d mass of perverse ingenuity, of tinsel erudition, of imbecile incredibility and of artful misrepresentation.' In 1842, H o l m e s delivered a lecture entitled ' H o m e o p a t h y and Its Kindred D e l u s i o n s ' , in which he reiterated w h y Oliver Wendell Holmes
H a h n e m a n n ' s ideas did not m a k e sense
from a scientific point of view. He focused particularly on the extreme dilutions at the heart of homeopathy. O n e way to think about these dilutions is to consider the key ingredient being dissolved in ever greater volumes of liquid. Each time h o m e o p a t h s dilute the active ingredient by a factor of 100, they are effectively dissolving it in a volu m e of water or alcohol that is 100 times bigger, and they do this over and over again. H o l m e s used a calculation by the Italian physician Dr Panvini to explain the bizarre consequences of such repeated dilutions when applied to a starting ingredient of one drop of C h a m o m i l e : For the first dilution it would take 100 drops of alcohol. For the second dilution it would take 10,000 drops, or about a pint. For the third dilution it would take 100 pints. For the fourth dilution it would take 10,000 pints, or more than 1,000 gallons, and so on to the ninth dilution, which would take ten billion gallons, which he computed would fill the basin of Lake Agnano, a body of water two miles in circumference. The twelfth dilution would of course fill a million such lakes. By the time the seventeenth degree of dilution should be reached, the alcohol required would equal in quantity the waters of ten thousand Adriatic
110
TRICK OR TREATMENT?
seas. Swallowers of globules, one of your little pellets, moistened in the mingled waves of one million lakes of alcohol, each two miles in circumference, with which had been blended that one drop of Tincture of Camomile, would be of precisely the strength recommended for that medicine in your favorite Jahr's Manual, against the most sudden, frightful, and fatal diseases! In the same spirit, William Croswell D o a n e ( 1 8 3 2 - 1 9 1 3 ) also took a swipe at homeopathy. As the first Episcopal B i s h o p of Albany, N e w York, he penned a piece of doggerel entitled ' L i n e s on H o m o e o p a t h y ' : Stir the mixture well Lest it prove inferior, Then put half a drop Into Lake Superior. Every other day Take a drop in water, You'll be better soon Or at least you oughter. In E u r o p e Sir John F o r b e s , Q u e e n Victoria's physician, called homeopathy ' a n outrage to h u m a n r e a s o n ' , a view that was consistent with
the
entry
for
Encyclopaedia Britannica:
homeopathy
in
the
1891
edition
of the
' H a h n e m a n n ' s errors were g r e a t . . . He led
his followers far out of the track of sound views of disease.' Part of the r e a s o n for h o m e o p a t h y ' s d e c l i n e in p o p u l a r i t y w a s that the m e d i c a l e s t a b l i s h m e n t w a s t r a n s f o r m i n g itself from heroic and d a n g e r o u s into scientific and effective. Clinical trials, such as those that e x p o s e d the d a n g e r s of b l o o d l e t t i n g , w e r e steadily differentiating b e t w e e n h a z a r d o u s p r o c e d u r e s a n d effective c u r e s . A n d , a s e a c h d e c a d e p a s s e d , t h e r e w a s an i n c r e a s e d u n d e r s t a n d i n g of the true c a u s e s o f d i s e a s e . O n e o f the m o s t i m p o r t a n t m e d i c a l b r e a k t h r o u g h s took p l a c e d u r i n g the p r e v i o u s l y m e n t i o n e d 1854 L o n d o n c h o l e r a epidemic. T h e disease had first hit Britain in 1 8 3 1 , w h e n 23,000 people died; this w a s followed by the 1849 e p i d e m i c , which killed 53,000. During
T H E TRUTH A B O U T HOMEOPATHY
111
the 1849 epidemic the obstetrician Dr John Snow questioned the established theory that cholera was spread through the air by u n k n o w n poisonous vapours. He had been a pioneer of anaesthesia and had administered chloroform to Queen Victoria during the birth of Prince Leopold, so he k n e w exactly how gaseous poisons affected groups of people; if cholera was caused by a g a s , then entire populations should be affected, but instead the disease seemed to be selective about its victims. Therefore, he posited the radical theory that cholera was caused by contact with contaminated water and sewage. He put his theory to the test during the next cholera outbreak in 1854. In L o n d o n ' s S o h o , he made an observation that seemed to support his theory: Within 250 yards of the spot where Cambridge Street joins Broad Street there were upwards of 500 fatal attacks of cholera in 10 days. As soon as I became acquainted with the situation and extent of this eruption of cholera, I suspected some contamination of the water of the muchfrequented street-pump in Broad Street. To investigate his theory he plotted the location of every death on a m a p of Soho (see Figure 4) and, sure e n o u g h , the suspicious p u m p was at the epicentre. His theory was further backed by his observation that a local coffee s h o p that served water from the p u m p had nine customers w h o had contracted cholera. On the other hand, a nearby w o r k h o u s e with its o w n well had no cases, and e m p l o y e e s at the brewery on Broad Street had been unaffected because they drank their o w n produce. A key piece of evidence was the case of a w o m a n w h o died of cholera, even though she lived far from S o h o . Snow learned, however, that she had previously lived in Soho and had such a fondness for the sweet p u m p water that she had specially asked for some Broad Street water to be brought to her house. Based on all these observations, Snow persuaded t o w n officials to take the handle off the p u m p , which halted the supply of contaminated water and brought an e n d to the cholera outbreak. Snow, arguably the world's first epidemiologist, had demonstrated the p o w e r of the n e w scientific approach to medicine, and in 1866 Britain suffered its last cholera outbreak.
112
TRICK OR TREATMENT?
Figure 4 John Snow's map of cholera deaths in Soho, 1854. Each black oblong represents one death, and the Broad Street pump can be seen at the centre of the epidemic.
Other major scientific breakthroughs included vaccination, which had been growing in popularity since the start of the 1800s, and Joseph Lister's pioneering use of antiseptics in 1865. Thereafter Louis Pasteur invented vaccines for rabies and anthrax, thus contributing to the development of the g e r m theory of disease. E v e n m o r e importantly, Robert K o c h and his pupils identified the bacteria responsible for cholera, tuberculosis, diphtheria, typhoid, p n e u m o n i a , gonorrhoea, leprosy, b u b o n i c p l a g u e , tetanus and syphilis. K o c h deservedly received the 1905 Nobel Prize for Medicine for these discoveries. Without any c o m p a r a b l e achievements attributed to h o m e o p a t h y , and without any rigorous evidence or scientific rationale to support it, the use of these ultra-dilute homeopathic remedies continued to decline into the twentieth century in both Europe and A m e r i c a . For e x a m p l e , American h o m e o p a t h y was dealt a severe blow in 1910 when the Carnegie Foundation asked A b r a h a m Flexner to investigate w a y s of establishing higher standards for the admission, teaching and
THE TRUTH A B O U T HOMEOPATHY
113
graduation of medical students. O n e of the key r e c o m m e n d a t i o n s of the Flexner Report was that medical schools should offer a curriculum based on mainstream conventional practice, which effectively ended the teaching of homeopathy in major hospitals. H o m e o p a t h y continued its steady decline, and by the 1920s it seemed that it was destined to b e c o m e extinct around the world. T h e n , in 1925, there w a s a sudden and unexpected revival in G e r m a n y , the country where h o m e o p a t h y had been invented. T h e man behind the resurgence was an eminent surgeon called August Bier, w h o used the homeopathic principle of 'like cures like' to treat bronchitis with ether and to cure boils with sulphur. His patients responded well, so he wrote up his findings in a G e r m a n medical journal. This was the only paper on the subject of homeopathy to be published in G e r m a n y in 1925, but it triggered forty-five papers discussing homeopathy the following year, and over the next decade there was a renewed enthusiasm for the potential of ultra-dilute m e d i c i n e s . This was a timely development for the Third Reich, whose leaders sought to develop the Neue Deutsche Heilkunde (the N e w G e r m a n Medicine), an innovative medical system that would c o m b i n e the best of both modern
and traditional
implement
the
fully
Neue
m e d i c i n e . T h e first hospital to
Deutsche
Heilkunde
was
founded
in
Dresden in 1934 and was named after Rudolf H e s s , w h o was Hitler's deputy at the t i m e . Hess w a s strongly in favour of incorporating homeopathy
within
the
Neue
Deutsche
Heilkunde,
partly
because
he believed it to be highly effective, and partly because it had been invented by a G e r m a n . Furthermore, he viewed homeopathic remedies, most of which were cheap to manufacture, as a low-cost solution to meeting the needs of G e r m a n healthcare. M e a n w h i l e , the G e r m a n Ministry of Health w a s keen to test whether or not h o m e o p a t h y was genuinely effective. T h e Third Reich's chief medical officer, Dr Gerhard Wagner, instigated an unprecedented p r o g r a m m e of research, which involved sixty universities and cost hundreds of millions of R e i c h s m a r k s . T h e research effort started immediately after the 1937 Homeopathic World C o n g r e s s in Berlin and it continued for the next two years, with a particular focus on treating tuberculosis, anaemia and gonorrhoea. T h e team behind the
114
TRICK OR TREATMENT?
homeopathy research project included pharmacologists, toxicologists and, of course, h o m e o p a t h s , w h o together designed a series of detailed trials and then implemented t h e m rigorously. It is worth noting that those involved in the trials were a m o n g the most respected people in their fields, and they maintained the highest ethical and scientific standards in their research. T h e results w e r e about to be announced in 1939, but the outbreak of the Second World War prevented publication. T h e original d o c u m e n t s survived the war and were discussed again w h e n the senior researchers reconvened in 1947, but unfortunately their conclusions w e r e never formally announced. Worse still, the d o c u m e n t s have never been seen again. It seems that the results of the first comprehensive study of h o m e o p a t h y have been concealed, lost or destroyed. Nevertheless, there exists one very detailed account of the Nazi research p r o g r a m m e , which w a s written by Dr Fritz D o n n e r and published p o s t h u m o u s l y in
1 9 9 5 . D o n n e r had j o i n e d the Stuttgart
H o m e o p a t h i c Hospital in the mid-1930s and had contributed to the national research p r o g r a m m e in his capacity as a practising h o m e o path. According to Donner, w h o claims to have seen all the relevant d o c u m e n t s , none of the trials gave any indication in favour of the efficacy of homeopathy: 'It is unfortunately still not generally k n o w n that these comparative studies in the area of infectious diseases such as scarlet fever, m e a s l e s , w h o o p i n g c o u g h , typhus etc generated results which were not better for homeopathy than for p l a c e b o . ' He also added: ' N o t h i n g positive emerged from these tests . . . except the fact that it was indisputably established that the views [of homeopaths] were based on wishful thinking.' If D o n n e r was correct, then his statement would be a d a m n i n g indictment of homeopathy. T h e first comprehensive and rigorous prog r a m m e to test the claims of homeopathy, conducted by researchers w h o were sympathetic to the philosophy and w h o were to s o m e extent under pressure to prove its validity, had arrived at a wholly negative conclusion. Of course, we cannot be sure that D o n n e r ' s report was accurate, as the vital d o c u m e n t s have never resurfaced. It would, therefore, be wrong to c o n d e m n homeopathy based on the testimony of one m a n ' s view of research conducted seventy years a g o . But even if we
THE TRUTH A B O U T HOMEOPATHY
ignore the supposed negative results of the Nazi research p r o g r a m m e , it is still interesting to note that between H a h n e m a n n ' s initial research and the end of the Second World War, a period of s o m e one and a half centuries, nobody succeeded in publishing any conclusive scientific evidence to support the notion of homeopathy.
Nature's miracle After the Second World War, mainstream medicine in A m e r i c a and Europe continued its relentless progress, thanks to further important scientific breakthroughs such as antibiotics. M e a n w h i l e the h o m e o pathic tradition was m a n a g i n g to survive only with the patronage of some powerful and sympathetic supporters. For e x a m p l e , George VI was a fervent believer, so m u c h so that he even n a m e d one of his horses H y p e r i c u m , after the homeopathic r e m e d y based on St J o h n ' s wort; the horse went on to win the O n e T h o u s a n d Guineas at N e w m a r k e t in 1946. T w o years later, King George played an influential role in enabling homeopathic hospitals to c o m e under the umbrella of the newly formed National Health Service. In A m e r i c a , it was the influence of men like Senator Royal Copeland that allowed homeopathy to survive despite the general trend away from H a h n e m a n n ' s philosophy and towards the use of treatments with a more scientific and reliable foundation. Both a homeopath and a politician, Copeland successfully persuaded his colleagues that the 1938 Federal F o o d , D r u g , and Cosmetic Act should include the H o m e o p a t h i c P h a r m a c o p e i a of the United States. T h e Act was supposed to protect patients from unproven or disproven r e m e d i e s , and yet the claims of h o m e o p a t h y were still based merely on anecdote and H a h n e m a n n ' s preaching. S o , by including the entire homeopathic catalogue, the Act was giving undue credence to remedies that had no scientific basis. In India, homeopathy was not only surviving, but it was actually thriving at every level of society, and this success had nothing to do with political m a n o e u v r i n g or royal patronage. H o m e o p a t h y had been introduced there in 1829 by Dr Martin Honigberger, a Transylvanian physician w h o joined the court of Maharajah Ranjit Singh in Lahore.
116
TRICK OR TREATMENT?
T h e idea then spread rapidly throughout India, prospering largely because it was perceived as being in opposition to the imperialist m e d icine practised by the British invaders. Attitudes towards British medicine were so negative, in fact, that vaccination p r o g r a m m e s and attempts to quarantine plague casualties both failed dismally in the mid-nineteenth century. M o r e o v e r , Indians w h o wanted to pursue a career in conventional medicine often encountered prejudice w h e n they attempted to join the Indian Medical Service, so a m o r e realistic (and cheaper) career option was to train to be a homeopathic practitioner. It was also felt that h o m e o p a t h y and the Hindu Ayurvedic system of medicine could w o r k together in harmony, and there w e r e even rumours that H a h n e m a n n himself had studied traditional Indian m e d i c i n e . As the decades passed, tens of millions of Indians grew to rely solely on h o m e o p a t h y for their healthcare. A n d , having imported h o m e o p a t h y from the West, India then exported it back to the West in the 1970s. At a time w h e n Western patients were looking to the East for alternative
systems of medicine - such as acupuncture and
Ayurvedic therapies - they also began to e m b r a c e h o m e o p a t h y once again. It w a s considered by m a n y Westerners to be an exotic, natural, holistic and individualized form of m e d i c i n e , and an antidote to the corporate medicine being peddled by giant pharmaceutical corporations in E u r o p e and A m e r i c a . M e a n w h i l e , Western scientists continued to scoff. T h e r e were a few scientific trials examining the benefits of homeopathy in the 1950s, 1960s and 1970s, but they were so flimsy that the results w e r e unreliable. In short, there w a s still no sound evidence to support the idea that such ultra-dilute solutions could act as meaningful medicines. Therefore scientists still considered it absurd that any medical system could be built upon this principle. Scientists even began to p o k e fun at h o m e o p a t h s . For e x a m p l e , because homeopathic liquid remedies are so dilute that they often contain only water, scientists w o u l d sarcastically endorse their use for the treatment of one particular medical condition, namely dehydration. Or they w o u l d j o k i n g l y offer to m a k e e a c h other a drink of homeopathic coffee, which w a s presumably incredibly diluted and yet
THE TRUTH A B O U T HOMEOPATHY
117
tasted incredibly strong, because h o m e o p a t h s believe that lower amounts of active ingredient are associated with greater potency. Similar logic also implied that a patient w h o forgot to take a homeopathic r e m e d y might die of an overdose. H o m e o p a t h s accepted that repeated dilution inevitably r e m o v e s the presence of the active ingredient, and sure e n o u g h chemical analysis has always confirmed that ' h i g h - p o t e n c y ' homeopathic remedies are based on nothing more than pure water. H o m e o p a t h s were a d a m a n t , however, that this water w a s special because it had a m e m o r y of the active ingredient that it o n c e contained. This caused the Australian Council Against Health Fraud to m a k e fun of h o m e o p a t h y by pointing out that this m e m o r y must be highly selective: 'Strangely, the water offered as treatment does not r e m e m b e r the bladders it has been stored in, or the chemicals that m a y have c o m e into contact with its m o l e cules, or the other contents of the sewers it m a y have been in, or the cosmic radiation which has blasted through it.' T h e n , in J u n e
1988, the
laughing suddenly
stopped. Nature,
arguably the most respected science journal in the world, published a research paper with the snappy title ' H u m a n basophil degranulation triggered by very dilute antiserum against I g E ' . It took a little deciphering before non-specialists could appreciate the significance of the paper, but very rapidly it b e c a m e clear that here was a piece of research that seemed to back up s o m e of the claims of h o m e o p a t h s . If the p a p e r w a s correct, then ultra-dilute solutions that did not contain
any
active
i n g r e d i e n t did
indeed
have
an
impact on
biological systems. This could only be possible if the ingredient had left a m e m o r y of itself in the water. In turn, such a discovery would imply that h o m e o p a t h s might have been right all along. This piece of research, which has b e c o m e the most famous experiment in the history of homeopathy, was conducted by a charismatic French scientist n a m e d Jacques Benveniste, a former racing driver w h o had taken up medical research after suffering a back injury. Although he published several important scientific papers on a variety of subjects during the course of his career, he would ultimately be r e m e m b e r e d only for his Nature paper on homeopathy, which shocked the scientific establishment and m a d e headlines around the world.
118
TRICK OR TREATMENT?
Benveniste's
controversial
paper
had
surprisingly
humble
b e g i n n i n g s . T h e research b e g a n w h e n one of his colleagues w a s looking at h o w basophils, a type of white blood cell, reacted to a particular allergen. This is akin to the allergic reaction that might be e x p e r i e n c e d w h e n pollen hits the e y e , but on a m u c h smaller scale. B e n v e n i s t e ' s c h o s e n allergen w a s supposed to be only mildly diluted, but the technician accidentally created a solution so dilute that it w a s devoid of the allergen. N e v e r t h e l e s s , the technician was stunned to find that the solution still had a significant impact on the b a s o p h i l s . B e n v e n i s t e w a s equally astonished, so he asked for the unplanned ultra-dilution e x p e r i m e n t to be repeated. A g a i n , the basophils s e e m e d to react to an allergen that was no longer in the solution. B e n v e n i s t e was not a w a r e of h o m e o p a t h y at the t i m e , but it w a s not long before s o m e o n e pointed out that his e x p e r i m e n t s w e r e demonstrating the sorts of effects that h o m e o p a t h s h a d b e e n c h a m p i o n i n g for t w o centuries. T h e results implied that water had s o m e kind of m e m o r y of what it had previously contained, and that this m e m o r y could h a v e a biological i m p a c t . It w a s such a weird conclusion that Benveniste later c o m m e n t e d , 'It w a s like shaking your car keys in the Seine at Paris and then discovering that water taken from the m o u t h of the river would start your car!' T h e French team continued researching the idea of water m e m o r y for a n o t h e r t w o y e a r s . T h r o u g h o u t this p e r i o d
they
achieved
consistently positive results. For the first time ever, h o m e o p a t h s could argue that here was scientific evidence to support the m e c h a n i s m s underlying homeopathy. Previously, supporters of h o m e o p a t h y had been forced to rely on arguments that w e r e far from convincing. For e x a m p l e , h o m e o p a t h s would argue that h o m e o p a t h y w o r k e d in a similar w a y to vaccination. Vaccination is also a treatment whereby tiny a m o u n t s of what causes an illness can be used to c o m b a t that illness. At first this seems persuasive, but there is a major difference between h o m e o p a t h y and vaccination. T h e a m o u n t s of active ingredient used in vaccines might be tiny, perhaps just a few m i c r o g r a m s , but this is still vast c o m p a r e d to a homeopathic remedy. A vaccine contains billions of viruses or virus fragments, whereas most homeopathic remedies do not contain a
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single molecule of the active ingredient. The flawed analogy between vaccines and homeopathy has been promoted by homeopaths since the nineteenth century, when Oliver Wendell Holmes rebutted it by pointing out that it was akin to 'arguing that a pebble may produce a mountain, because an acorn can b e c o m e a forest'. H a v i n g satisfied himself that his research findings w e r e valid, B e n v e n i s t e sent a p a p e r describing his e x p e r i m e n t s to J o h n M a d d o x , editor of Nature. M a d d o x duly had the p a p e r refereed, w h i c h is a standard p r o c e d u r e that allows
i n d e p e n d e n t scientists to c h e c k
any n e w results and discuss w h e t h e r or not the research has been c o n d u c t e d properly. T h e e x p e r i m e n t a l protocol s e e m e d to be in order, but the claims in the p a p e r w e r e so extraordinary that M a d d o x took the step of adding a disclaimer alongside the published paper. T h e last time that M a d d o x had adopted this highly u n u s u a l a p p r o a c h w a s back in 1974, w h e n he published a paper about Uri G e l l e r ' s s u p p o s e d s p o o n - b e n d i n g p o w e r s . T h e disclaimer for B e n v e n i s t e ' s p a p e r read: 'Editorial reservation: R e a d e r s of this article m a y share the
incredulity of the
m a n y referees
. . . Nature has therefore
arranged for i n d e p e n d e n t investigators to o b s e r v e repetitions of the e x p e r i m e n t s . ' In other w o r d s , Nature decided to publish Benveniste's w o r k , but with the caveat that the journal would re-check the research by sending a team of experts to visit the French laboratory. T h e team was led by M a d d o x himself, and he was joined by Walter Stewart (a chemist) and J a m e s Randi (a magician). Randi's inclusion raised some e y e b r o w s , but he had an international reputation for debunking extraordinary claims and uncovering scientific fraud. To illustrate his attitude, Randi w o u l d often explain that if his neighbour claimed to have a goat in the garden then he would probably believe h i m , but if the neighbour said he had a unicorn then Randi would probably want to check h o w firmly its horn was attached. Randi had established himself as one of the w o r l d ' s leading sceptics back in 1964, when he hit the headlines by offering a reward of $10,000 to anyone w h o could prove the existence of any paranormal p h e n o m e n o n , which included therapies such as homeopathy that are contrary to the principles of science. T h e prize fund had steadily increased to $1 million by
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TRICK OR TREATMENT?
result. T h e A m a z i n g R a n d i , as he is k n o w n on stage, amused the crowd with a few card tricks to help ease the tension. Eventually D a v e n a s completed her analysis. T h e secret codes were revealed and the Nature team identified which test tubes had been treated homeopathically. T h i s t i m e the results s h o w e d that the basophils in the homeopathically treated samples had not reacted differently from the control basophils treated with plain water. T h e experiment had failed to demonstrate the sort of effects that Benveniste had been finding for the last two years. T h e results showed no evidence to support h o m e o p a t h y , and instead they were in line with conventional scientific thinking and all the k n o w n laws of physics, chemistry and biology. S o m e of Benveniste's colleagues burst into tears at the a n n o u n c e m e n t . Subsequently it e m e r g e d that Benveniste had never personally conducted any of the e x p e r i m e n t s , but had always left everything to D a v e n a s . Moreover, she had always conducted the analysis in an unblinded manner. This meant that it was highly likely that she had accidentally and consistently introduced biases into the results, particularly as she herself was already a strong believer in the p o w e r of homeopathy and was keen to prove its efficacy. W h e n Nature published the results of its investigation, the journal pointed out several problems with Benveniste's approach to research. T h e s e criticisms included statements such as: ' W e believe that experimental data have been uncritically assessed and their imperfections inadequately reported.' Moreover, the journal highlighted the fact that two of the researchers w h o had contributed to Benveniste's original paper had been partially funded by a French homeopathic c o m p a n y with an annual turnover of over € 100 million. Corporate funding is not necessarily problematic, but such potential conflicts of interest had not been formally disclosed. Despite these criticisms, the Nature investigators were keen to stress that they were not accusing Benveniste of deliberate fraud, but merely that he and his team were deluding themselves and had not been conducting their experiments rigorously. A lack of rigour, particularly a lack of blinding, can seriously bias any scientific result even for the most honest and well-intentioned scientist. Imagine the following scenario: a scientist has staked his
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TRICK OR TREATMENT?
reputation on the hypothesis that men have superior spatial awareness and motor skills, and he thinks he can demonstrate that this is the case by inviting m e n and w o m e n to draw freehand circles and then c o m paring the quality of their d r a w i n g s . T h e experiment begins - the m e n and w o m e n draw their circles, they write their names at the top of the papers, the drawings are collected by an assistant and handed to the scientist, w h o j u d g e s the circles by eye and gives each one marks out of ten. H o w e v e r , because he can see the n a m e s of the artists at the top of each d r a w i n g , he might be tempted subconsciously to m a r k the m e n ' s circles m o r e generously. Consequently, regardless of the truth, it is more likely that the resulting data would support his hypothesis that m e n are better than w o m e n at drawing circles. By contrast, if the experiment were to be repeated and the artists were given n u m b e r s to disguise their g e n d e r temporarily, then the prejudiced scientist b e c o m e s blinded and is more likely to give a fairer assessment of each circle. T h e new result is likely to be more reliable. In the B e n v e n i s t e c a s e , the p r o b l e m w a s that D a v e n a s w a s unblinded and prejudiced in favour of homeopathy, and this combination of factors could have biased her results. In particular, D a v e n a s ' s experiments required her to j u d g e whether a homeopathic preparation caused blood cells to exhibit an allergic reaction, which is not a clearcut decision, even when the cells are viewed through a microscope. Indeed, j u d g i n g the extent of a cell's allergic reaction is similar to examining a circle's roundness: both are equally prone to personal interpretation and bias. For example, Davenas would have come across many borderline cases - has the cell undergone an allergic reaction or not? There might have been a subconscious temptation to judge such borderline cells as exhibiting
allergic
reactions
if she k n e w that they had been treated
homeopathically. Or she might have been subconsciously tempted to give the opposite judgement if she knew that they had been treated with plain water. However, by asking Davenas to repeat the experiment without any labels on the test tubes, the Nature investigators ensured that she was blind and unbiased in her decisions; whereupon the homeopathic solutions and water led to similar results. A fair test had shown that the homeopathic solutions had no impact on the basophil cells.
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While Benveniste readily accepted some elements of the criticism, he steadfastly defended the core of his research and argued that the results that he had accumulated over the course of t w o years could not be negated by what the Nature team had observed in just a few d a y s . He explained that the mistakes that had been witnessed by M a d d o x , Randi and Stewart were caused by the unusual circumstances, namely that his team was working under intense pressure and in the media spotlight. Benveniste remained convinced that his work w o u l d ultimately be recognized with a N o b e l Prize, but instead he was merely rewarded with a satirical award k n o w n as the Ig Nobel Prize. In fact, he w o n an Ig Nobel Prize in 1991 and then another one in 1998, m a k i n g h i m the first scientist to win two Ig N o b e l s . As the years passed, Benveniste saw his scientific reputation decline in the press and a m o n g his peers, which led him to complain that he was being victimized. He even c o m pared himself to Galileo, because they had both been subjected to attacks when they dared to speak out against the establishment. This was a flawed comparison for two major reasons. First, Galileo was attacked largely by the religious establishment, rather than by his scientific peers. S e c o n d , Galileo was in a different class to Benveniste - after all, Galileo's observations stood up to scrutiny and his experimental results were replicated by others. Benveniste struggled to retain his academic post as a result of the Nature debacle, but he was determined not to abandon his research, so he established a c o m p a n y called DigiBio to nurture and promote his ideas. A m o n g their wilder p r o n o u n c e m e n t s , researchers at DigiBio stated that not only could water hold a m e m o r y of what it had previously contained, but that this m e m o r y could also be digitized, transmitted via email and reintroduced into another sample of water, which in turn could affect basophil cells. Although Benveniste died in 2 0 0 4 , DigiBio has continued its campaign to have his ideas taken seriously. Its website proclaims: From the first high dilution experiments in 1984 to the present, thousands of experiments have been made, enriching and considerably consolidating our initial knowledge. Up to now, we must observe that
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TRICK OR TREATMENT?
not a single flaw has been discovered in these experiments and that no valid counter-experiments have ever been proposed.
In fact, within a year of Benveniste's original 1988 paper, Nature had published three papers by scientists w h o failed to reproduce the supposed effect of ultra-dilute solutions. Even the U . S . Defense A d v a n c e d Research Projects Agency ( D A R P A ) collaborated with h o m e o p a t h s to test D i g i B i o ' s claim that Benveniste's effects could be digitized and sent via e m a i l , but they c a m e to the following conclusion: ' O u r t e a m found no replicable effects from digital signals.' On the other hand, there have been occasional papers that claim to replicate the sort of effects observed by Benveniste, but so far none of t h e m has consistently or convincingly presented the sort of evidence that would posthumously vindicate the F r e n c h m a n . In
1999, Dr
A n d r e w Vickers looked at 120 research papers related to Benveniste's work and other types of basic research into the actions of homeopathic remedies.
At
the
time,
he
was
based
at
the
Royal
London
H o m o e o p a t h i c Hospital, so he was certainly o p e n - m i n d e d about the potential of homeopathy. Yet Vickers was struck by the failure of independent scientists to replicate any homeopathic effect: 'In the few instances where a research team has set out to replicate the work of another, either the results were negative or the methodology was questionable.' Independent replication is a vital part of how science progresses. One single set of experiments can be wrong for a range of reasons, such as lack of rigour, fraud or just bad luck, so independent replication is a way of checking (and re-checking) that the original discovery is genuine. Benveniste's research had failed this test. Indeed, J a m e s Randi has continued to offer his $1 million to anyone w h o can independently reproduce the effects claimed by Benveniste. B B C television took up the challenge as part of its Horizon science documentary series, gathering together a team of scientists to oversee the project. T h e y examined the effect of a homeopathically diluted histamine on cells, and c o m p a r e d this with the effect of pure water. Histamine is associated with allergic responses in cells, but would it still cause cells to react if it had been diluted to the extent that it was no longer present? Professor Martin Bland of St G e o r g e ' s Hospital
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125
Medical School announced the final result: ' T h e r e ' s absolutely no evidence at all to say that there is any difference between the solution that started off as pure water and the solution that started off with the histamine.' As anecdotal evidence to reinforce the point, Randi mentioned the following story during the p r o g r a m m e : T also cons u m e d sixty-four times the prescribed dosage of homeopathic sleeping pills and d i d n ' t even feel drowsy. I did this before a meeting of the US Congress - if that d o e s n ' t put you to sleep, nothing will.' While biologists were trying and failing to find evidence for homeopathy acting at a fundamental cellular level, physicists tried to examine homeopathy
at
a
basic
molecular
level.
It
was
clear
that
ultra-dilute h o m e o p a t h i c solutions contained only water and no molecules of the active ingredient, but some physicists wondered if the water molecules somehow had altered their arrangement in order to retain a memory of the earlier ingredient. Over the last two decades, physicists have published the results of dozens of experiments examining the molecular structure of normal water versus homeopathically prepared water. They have used powerful and arcane techniques such as nuclear magnetic resonance ( N M R ) , Raman spectroscopy and light absorption to look for the slightest evidence that water has a memory of what it once contained. Unfortunately, a review of these studies published in The Journal of Alternative and Complementary Medicine in 2003 showed that these experiments were generally of poor quality and prone to errors. For e x a m p l e , one N M R experiment claimed to detect a difference between the molecules in ordinary water and those in a homeopathic remedy, but in the end this was attributed to a problem with the equipment. T h e N M R apparatus is supplied with test tubes m a d e of soda glass, which is not a very stable form of glass. H e n c e , w h e n the homeopathic
solution w a s
s h a k e n d u r i n g its p r e p a r a t i o n , glass
molecules were leached into the solution. Not surprisingly, this h o m e opathic solution responded differently to the pure water in terms of its N M R profile, which initially gave the misleading impression that the homeopathic solution was demonstrating a water-memory effect. Sure e n o u g h , when another research team repeated the experiment with borosilicate glass test tubes, which are m u c h more stable than soda
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TRICK OR TREATMENT?
glass, the N M R instrument could no longer detect any difference between water and homeopathic remedies. Yet again, experiments have so far failed to find anything surprising about the behaviour of molecules in homeopathic solutions. In summary, h o m e o p a t h s have been disappointed that physicists probing water molecules have found nothing special about h o m e o pathic remedies. Similarly, biologists looking at single cells h a v e not m a d e any great breakthroughs in finding convincing evidence that might support homeopathy. All of this, however, matters very little in terms of the m a i n h o m e opathy debate, because what happens at the molecular or cellular level is of m u c h less interest than what happens to patients. Forget biology or physics, because homeopathy is all about medicine. T h e fundamental question is straightforward: does homeopathy heal patients? H o m e o p a t h s , of course, have always been confident that their remedies cured a range of s y m p t o m s , but in order to persuade doctors and everyone else that h o m e o p a t h y was truly effective, they needed concrete evidence from scientific trials. We have explained in previous chapters that the most conclusive type of clinical trial is the r a n d o m ized, placebo-controlled, double-blind trial;
if such trials could
generate results that supported H a h n e m a n n ' s ideas, then this would force the medical establishment to e m b r a c e homeopathy. Alternatively, if these studies failed to show that ultra-dilute solutions offered any benefit, then this would mean that homeopathy was nothing more than quackery. As the twenty-first century approached, rigorous trials were about to be conducted on a massive scale. T h e results would eventually settle the debate over h o m e o p a t h y once and for all.
Homeopathy on trial For many h o m e o p a t h s , the lack of definitive scientific evidence to support their remedies was not a matter of concern, because they could cite n u m e r o u s e x a m p l e s that seemed to demonstrate the effectiveness of their interventions. For instance, The Complete Idiot's Guide to Homeopathy by David W. Sollars includes a story told by a mother w h o treated her son, Kailin. T h e boy had burned his arm at a barbecue,
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but luckily the people hosting the occasion had just purchased a homeopathic h o m e kit: I told them to get it quickly as I held my ice-filled glass on his arm, which helped the pain a little. Within a couple of minutes the kit arrived and I chose the remedy Cantharis and gave Kailin a dose. Within two or three minutes the pain stopped and we all watched over the next fifteen minutes as the skin started to lighten in color. I repeated the remedy several times, whenever he said the pain was starting to return. By the next day the bum was all but gone and totally cleared in two days. We were all amazed that no blisters were ever formed. This case seems impressive, but it was dissected and undermined by Jay W. Shelton, author of Homeopathy. He identifies four questions that challenge the significance of this and similar c a s e s . First, this seems like a classic first-degree burn, the least serious t y p e , which causes d a m a g e only to the surface of the skin; so should we really be so surprised
a b o u t the
lack of b l i s t e r s ?
Second, why
should
homeopathy get any credit, when the recovery process might have been entirely due to the b o d y ' s natural healing ability? Third, is it possible that the ice-filled glass played the most important role in helping the child? Finally, if homeopathy did indeed help the patient, then could its influence have been entirely due to the placebo effect? In the previous chapter we saw the p o w e r of placebo, which is so great that it can m a k e a useless therapy appear like a truly valuable o n e , as long as the patient has confidence in the therapy. W h e n scientists dismiss such h u m a n cases as partly or wholly due to the placebo effect, h o m e o p a t h s often cite cases of animal healing, because they believe that animals are i m m u n e to the placebo effect. It is true that many pet o w n e r s and farmers feel that h o m e o p a t h y helps their animals, and it is also true that these creatures are oblivious to what a pill is supposed to d o , but the value of these anecdotes collapses under closer scrutiny. For instance, the animal is unaware of which treatment it is receiving or h o w it is supposed to respond, yet the fact remains that the person monitoring the animal is fully a w a r e . In other w o r d s , the animal
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TRICK OR TREATMENT?
is effectively blinded to what is h a p p e n i n g , but the person reporting the events is unblinded and is therefore unreliable. For instance, an anxious pet o w n e r w h o has faith in h o m e o p a t h y might focus on any sign of i m p r o v e m e n t based on expectation and h o p e , while ignoring s y m p t o m s that have deteriorated. Even if the animal has definitely improved beyond the placebo effect, then this could be due to a variety of factors other than the homeopathic pill, such as the extra care and attention being provided by a caring and concerned owner. In short, the medical establishment will not accept anecdotal evidence - based on either h u m a n or animal patients - as reliable e n o u g h to support h o m e o p a t h y or any other treatment. No a m o u n t of anecdote can stand in place of firm evidence, or, as scientists like to say, ' T h e plural of anecdote is not data.' Medical scientists place an emphasis on data because the best way to analyse the impact of any therapy is to look at the results from rigorous scientific investigations, particularly clinical trials. By way of a quick recap, you will recall that Chapter 1 revealed the uncanny ability of the randomized clinical trial to show which therapies work and which do not. Chapter 2 then built on that foundation to show how this technique could be used to test the claims of acupuncturists. So what happens when homeopathy is submitted to the same scientific scrutiny? In theory it should be m u c h easier to test homeopathy than acupuncture, because it is m u c h more obvious h o w to take into account the placebo effect. A homeopathic trial would require the random assignment of patients into t w o groups, namely a group treated homeopathically and a placebo control g r o u p . T h e patients w o u l d not be told to which group they had been assigned. Both groups would receive an empathic encounter with a h o m o e o p a t h , w h o would also be blinded, inasmuch as he or she would not know which patients belonged to which group. Researchers would then create t w o batches of pills that w e r e identical, except that one batch w o u l d have been treated with a drop of homeopathic solution and the other batch would remain plain. T h e treatment group would receive the homeopathic pill and the control group would receive the plain pill. Patients in both groups should experience some i m p r o v e m e n t , simply due to the placebo effect. T h e critical question is this: does the treatment group on
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1988, so if the team endorsed Benveniste's result then it would lead to Randi writing out a very large c h e q u e to the F r e n c h m a n . T h e investigation started within a w e e k of the p a p e r ' s publication. It lasted four days and involved replicating the key experiment, with M a d d o x , Stewart and Randi monitoring every stage and checking for flaws in the procedure. T h e y observed the handling of several test tubes containing basophil blood cells, s o m e of which were treated with the homeopathic allergen solution, while the rest were treated with plain water and acted as a control. T h e task of analysing the test tubes w a s given to Elisabeth D a v e n a s , Benveniste's assistant, and yet again the result was the same as it had been for the last t w o years. M o r e of the homeopathically treated cells showed an allergic response than the control cells, implying that the homeopathic solution had genuinely triggered a reaction in the blood cells. Even though the homeopathic solution no longer contained any allergen, its ' m e m o r y ' of the allergen seemed to be having an impact. T h e experiment had been successfully replicated. The
investigators, however, were
still
not c o n v i n c e d . W h e n
D a v e n a s analysed the test tubes she knew exactly which ones had been treated with the homeopathic solution, so the investigators were concerned that her analysis might have been deliberately or unconsciously biased. In Chapter 2 we discussed the issue of blinding, which m e a n s that patients in a trial should not be aware of whether they are receiving the real treatment or the placebo control treatment. Blinding is equally applicable to doctors and scientists. T h e y should not be aware of whether they are administering or studying the real or the control treatment. T h e aim of blinding is to minimize b i a s , and to avoid anybody being influenced by their expectations. Consequently, the Nature team requested Davenas to repeat the analysis, but only after they had blinded her to the contents of the test tubes. M a d d o x , Randi and Stewart went into a separate r o o m , blanked out the w i n d o w s with n e w s p a p e r s , r e m o v e d the labels from the test tubes and replaced them with secret codes that they would later use to identify which samples had been treated with homeopathic solution and which had been treated with water. Davenas repeated her analysis, while colleagues from around the laboratory gathered to await the final
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average show significant improvements over and above the control group? If the answer is ' y e s ' , then this would clearly indicate that homeopathy is genuinely effective. If, however, the answer is ' n o ' and each group shows a similar response, then homeopathy would be exposed as having nothing more than a placebo effect. Before looking at the trials conducted with h u m a n s , it is interesting to note that there h a v e been some randomized placebo-controlled trials of h o m e o p a t h y ' s impact on animals. T h e overall conclusion of the major studies is that homeopathy offers no benefit to a n i m a l s . F o r e x a m p l e , in 2003 the National Veterinary Institute in Sweden conducted a double-blind trial of the homeopathic r e m e d y Podophyllum as a cure for diarrhoea in calves, and it found no evidence for the efficacy of homeopathy. M o r e recently, a C a m b r i d g e University research group conducted a double-blind trial to c o m p a r e h o m e o p a t h y against a placebo as a treatment for mastitis for 250 c o w s . An objective w a y of checking for any i m p r o v e m e n t in inflammation of the udder is to count the n u m b e r of white blood cells in the c o w ' s milk, and the conclusion w a s that homeopathy was no more effective than the placebo. W h e n scientists looked at the evidence in terms of h u m a n patients, the picture was more complicated. T h e good n e w s was that by the mid 1990s there had been well over 100 published trials seeking to decide the therapeutic value of homeopathy. T h e bad n e w s was that this mountain of research consisted largely of poorly conducted trials, often with inadequate randomization, or with no proper control g r o u p , or with insufficient n u m b e r s of patients. N o n e of these trials was able to give a definitive answer to whether or not h o m e o p a t h y benefited patients beyond the placebo effect. With nothing to rely on except unconvincing anecdotes and inconclusive trials, the arguments for and against homeopathy were deadlocked. Then, in 1997, an international research team took a dramatic step towards settling the homeopathy debate. T h e y were led by Klaus Linde, a senior figure at the Munich-based Centre for Complementary Medicine Research. He and his colleagues decided to examine the considerable body of research into homeopathy in order to develop an over-arching conclusion that took into consideration each and every trial. This is k n o w n as a meta-analysis, which means an
130
TRICK OR TREATMENT?
analysis of various analyses. In other w o r d s , each individual trial into homeopathy concluded with an analysis of its o w n data, and Linde was proposing to pool all these separate analyses in order to generate a new, more reliable, overall result. Meta-analysis can be considered as a particular type of systematic review, a concept that was introduced in the previous chapter. Like a systematic review, a meta-analysis attempts to draw an overall conclusion from several separate trials, except that a meta-analysis tends to involve a more mathematical approach. Although the term meta-analysis might be unfamiliar to m a n y readers, it is a concept that crops up in a range of familiar situations where it is important to m a k e sense of lots of data. In the run-up to a general election, for instance, several newspapers might publish opinion polls with conflicting results. In this situation it would be sensible to c o m b i n e all the data from all the polls, which ought to lead to a more reliable conclusion than any single poll, because the metapoll (i.e. poll of polls) reflects the complete data from a m u c h larger group of voters. T h e p o w e r of meta-analysis b e c o m e s obvious if we e x a m i n e some hypothetical sets of data concerning astrology. If your astrological sign determined your character, then an astrologer should be able to identify a person's star sign after an interview. Imagine that a series of five experiments is conducted around the world by rival research g r o u p s . In each c a s e , the same astrologer is simply asked to identify correctly a person's star sign based on a five-minute conversation. T h e experiments range in size from 20 to 290 participants, but the protocol is the same in each case. C h a n c e alone would give rise to a success rate of one correct identification (or hit) in t w e l v e , so the astrologer would have to do significantly better than this to give credence to the notion of astrology. T h e five experiments lead to the following success rates: Experiment 1
12
hits out of
170
(equivalent to 0.85 hits out of 12)
Experiment 2
5
hits out of
50
(equivalent to 1.20 hits out of 12)
Experiment 3
5
hits out of
20
(equivalent to 3.00 hits out of 12)
Experiment 4
6
hits out of
70
(equivalent to 1.03 hits out of 12)
Experiment 5
21
hits out of 290
(equivalent to 0.87 hits out of 12)
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131
On its o w n , the third experiment seems to suggest that astrology w o r k s , because a hit rate equivalent to 5 out of 20 is m u c h higher than chance would predict. Indeed, the majority of experiments (three out of five) imply a higher than expected hit rate, so one way to interpret these sets of data w o u l d be to c o n c l u d e that, in g e n e r a l , the experiments support astrology. H o w e v e r , a meta-analysis would c o m e to a different conclusion. T h e meta-analysis would start by pointing out that the n u m b e r of attempts m a d e by the astrologer in any one of the experiments was relatively small, and therefore the result of any single experiment could be explained by mere c h a n c e . In other w o r d s , the result of any o n e of these e x p e r i m e n t s is effectively
m e a n i n g l e s s . N e x t , the
researcher doing the meta-analysis would c o m b i n e all the data from the individual experiments as though they were part of one giant experiment. This tells us that the astrologer had 49 hits out of 600 in total, which is equivalent to a hit rate of 0.98 out of 12, which is very close to 1 out of 12, the hit rate expected by chance alone. T h e conclusion of this hypothetical meta-analysis would be that the astrologer has demonstrated no special ability to determine a person's star sign based on their personality. This conclusion is far more reliable than anything that could have been deduced solely from any one of the small-scale experiments. In scientific terms: a meta-analysis is said to minimize random and selection biases. Turning to medical research, there are n u m e r o u s treatments that have been tested by meta-analysis. For e x a m p l e , in the
1980s
researchers wanted to know if corticosteroid medication could help reduce respiratory problems in premature babies. They designed a trial which involved giving the treatment to pregnant w o m e n likely to have premature births and then monitoring the babies born to these mothers. Ideally, the researchers would have conducted one trial in a single hospital with a large n u m b e r of c a s e s , but it was only possible to identify a few suitable cases each year per hospital, so it would have taken several years to accumulate sufficient data in this manner. Instead, the researchers conducted several trials across several hospitals. T h e results of each individual trial varied from hospital to hospital, because the n u m b e r s of babies in each trial was small and
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TRICK OR TREATMENT?
random influences were large. Yet a meta-analysis of all the trials showed with certainty that corticosteroid medication during pregnancy benefited premature babies. This treatment is part of the reason why the n u m b e r of infant deaths due to respiratory distress s y n d r o m e has fallen dramatically - there were 25,000 such deaths in A m e r i c a in the early 1950s and today the n u m b e r is fewer than 5 0 0 . T h e meta-analysis in the premature baby study was fairly straightforward, because the individual trials were similar to each other and so they could be merged easily. T h e same is true of the hypothetical example concerning astrology. Unfortunately, conducting a metaanalysis is often a messy business, because the individual trials have generally been conducted in different w a y s . Trials for the same medication might vary according to the dose given, the period of monitoring, and so on. In Linde's case, the meta-analysis was particularly problematic. In order to d r a w a conclusion about the efficacy of homeopathy, Linde was attempting to include homeopathy trials investigating a huge variety of r e m e d i e s , across a range of potencies, being used to treat a wide range of conditions, such as asthma and minor b u r n s . Linde trawled through the computer databases, attended n u m e r o u s homeopathic conferences, contacted researchers
in the field and
eventually found 186 published trials on homeopathy. He and his colleagues then decided to exclude from his meta-analysis those trials that failed to meet certain basic conditions. For e x a m p l e , in addition to a group of patients being treated with homeopathy and a control group of patients, an acceptable trial had to have a placebo for the controlgroup patients, or there had to be random allocation of patients to the treatment and control g r o u p s . This left eighty-nine trials. W h a t followed was months of careful statistical analysis, so that each trial contributed appropriately to the final result. For e x a m p l e , the result of a very small trial would carry very little weight in the overall conclusion, because the reliability of a trial's result is closely linked to the n u m b e r of participants in the trial. T h e meta-analysis was eventually published in September 1997 in the Lancet. It was one of the most controversial medical research papers of the year, because its conclusion endorsed exactly what
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h o m e o p a t h s had been saying for t w o centuries. On a v e r a g e , patients receiving homeopathy w e r e m u c h more likely to show signs of improvement than those patients in the control groups receiving placebo. T h e paper concluded: ' T h e results of our meta-analysis are not c o m p a t i b l e with the hypothesis that the clinical effects of homeopathy are completely due to placebo.' In other w o r d s , according to the meta-analysis, homeopathy w a s genuinely effective. Not surprisingly, Linde's conclusion was questioned by opponents of homeopathy. Critics argued that his meta-analysis had been too lax, inasmuch as it had included too m a n y trials of relatively poor quality, and they feared that these might have biased the overall conclusion in favour of homeopathy. H o m e o p a t h s responded that there had been a quality threshold, which Linde had implemented specifically in order to exclude poor-quality trials. R e m e m b e r , Linde had included only those trials that were placebo-controlled or randomized. Nevertheless, the critics were still unhappy, as they maintained that the quality threshold had not been set high e n o u g h . Because poorer-quality trials are more likely to produce misleading results, researchers have developed techniques for assessing quality and weeding out those trials that should not be taken seriously. For e x a m p l e , the Oxford quality scoring system, developed in 1996 by Alejandro Jadad and his colleagues at Oxford University, can be used to give a trial a score between 0 points (very poor) and 5 points (rigorous). T h e system works by awarding or deducting points according to what appears in the published version of the trial. So if the research paper confirms that there was randomization of patients then it receives a point, yet this point can be deducted if the randomization appears to have been inadequate. Or the trial can score a point if the paper describes h o w the researchers dealt with the data from patients w h o dropped out from the trial. If the researchers have thought about this in detail and bothered to describe it in their research paper, then it is a good indication of their overall level of rigour. Critics pointed out that sixty-eight out of the eighty-nine trials in Linde's meta-analysis scored only 3 or less on the Oxford scale, which meant that three-quarters of the trials were substandard. Moreover, critics pointed out that restricting the meta-analysis to the higher-
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TRICK OR TREATMENT?
quality trials (4 or 5 points) drastically reduced the apparent efficacy of homeopathy. In fact, the conclusion of the twenty-one higherquality trials was that homeopathy offered either a small benefit for patients or no benefit at all. Despite the amount of data available from these twenty-one trials, it w a s still not possible to distinguish between these two possibilities. In time, Linde and his colleagues agreed that their critics had a valid point, and in 1999 they published a follow-up paper that re-examined the same data with a special emphasis on the quality of the individual trials. Linde wrote: 'We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results.' Then, referring back to the original metaanalysis, he stressed: 'It seems, therefore, likely that our meta-analysis at least over-estimated the effects of homeopathic treatments.' Linde's original 1997 paper had supported homeopathy, yet his revised 1999 paper was much more equivocal. His re-analysis of his own metaanalysis obviously disappointed the alternative medicine community, yet it was also frustrating for the medical establishment. Everyone was dissatisfied because Linde was neither able to claim that homeopathy was effective, nor was he able to dismiss it as a mere placebo. Despite the lack of clear-cut evidence in either direction, the public was increasingly turning towards homeopathy, either consulting practitioners or buying over-the-counter remedies. This gave researchers a renewed sense of urgency to test the therapy via larger, more rigorously conducted trials. H e n c e , h o m e o p a t h y was subjected to a much higher level of scrutiny from the late 1990s o n w a r d s . This eventually prompted Dr Aijing Shang and his colleagues at the University of Berne, Switzerland, to undertake a fresh meta-analysis of all the trials published up to January 2 0 0 3 . T h e medical research group at Berne, which is led by Professor Mathias E g g e r s , has a world-wide reputation for excellence and the Swiss government had provided the team with adequate funding for a fully rigorous meta-analysis. Hopes were high that Shang would at last be able to deliver a reliable conclusion. I n d e e d , after t w o c e n t u r i e s of bitter d i s p u t e b e t w e e n homeopaths and mainstream m e d i c s , S h a n g ' s meta-analysis w a s destined to decide, at last, w h o was right and w h o was w r o n g .
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Shang was ruthless in his d e m a n d for quality, which meant that his meta-analysis included only those trials with large n u m b e r s of participants, decent blinding and proper randomization. In the end, he was left with only eight h o m e o p a t h y trials. After studying the data from these eight trials - the best available trials on h o m e o p a t h y - his meta-analysis reached
its m o m e n t o u s c o n c l u s i o n . O n
average,
homeopathy was only very marginally more effective than placebo. S o , did this tiny marginal average benefit suggest that h o m e o p a t h y actually healed patients? Before answering this question, it is important to realize that the results of every scientific analysis are always associated with a level of uncertainty. For e x a m p l e , analysing the age of the Earth gives a result of 4,550 million years, and the error on this age is give or take 30 million years. T h e uncertainty associated with S h a n g ' s estimate on the efficacy of homeopathy w a s such that his conclusion was wholly compatible with the j u d g e m e n t that homeopathy acted as nothing more than a placebo. In fact, the most sensible interpretation of the metaanalysis was that homeopathy was indeed nothing more than a placebo. This interpretation b e c o m e s more convincing if we bear in mind another aspect of his research. While conducting his meta-analysis on homeopathy, he also conducted a meta-analysis for a whole variety of new, conventional pharmaceuticals. These pharmaceuticals had been tested on the same illnesses that had been considered for the homeopathy meta-analysis. In this secondary meta-analysis, Shang scrupulously applied exactly the same selection criteria to these conventional drug trials as he had done in his homeopathy meta-analysis. The result of his meta-analysis on conventional drug trials was that on average they worked. Although this result also had an uncertainty associated with it, the average benefit was so large that the effectiveness of these new conventional drugs was not in any doubt. T h e contrast between the homeopathic trials and the conventional drug trials was striking. H o m e o p a t h y had failed to show a clear benefit for patients and the result was compatible with homeopathy acting as a placebo, whereas conventional drugs had s h o w n a clear benefit for patients, which suggested that they do indeed have a genuine physio-
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TRICK OR TREATMENT?
logical impact on the body. This illustrates the stark difference between pseudo-medicine and real medicine. Shang published his results in the Lancet in August 2 0 0 5 . Based on his meta-analysis, he concluded: 'This finding is compatible with the notion that the clinical effects of homeopathy are placebo effects.' Reinforcing this point, the Lancet ran an editorial entitled ' T h e end of h o m e o p a t h y ' in which they argued that 'doctors need to be bold and honest with their patients about h o m e o p a t h y ' s lack of benefit'. This sparked major n e w s stories around the world, angering h o m e o p a t h s w h o refused to accept the conclusions of S h a n g ' s meta-analysis and the Lancet's a c c o m p a n y i n g statement. T h e y attempted to undermine the research by pointing out four key issues, but in fact each of their criticisms can be easily addressed. 1
H o m e o p a t h s might argue that S h a n g ' s paper indicates a positive effect for homeopathy, and that his meta-analysis therefore supports homeopathy. There is indeed a positive effect for homeopathy, but it is very small and entirely compatible with the treatment being a placebo. Shang's paper is the most comprehensive analysis of homeopathy during its 200-year history, and such a paucity of positive evidence has to be interpreted as a blow for homeopathy. Crucially, Shang's analysis confirms the results of about a dozen other meta-analyses and systematic reviews published over the last decade, all of which fail to show that homeopathy offers any benefit beyond placebo.
2
H o m e o p a t h s claim that Shang dredged the data, which means that the meta-analysis was conducted in such a way as to bias the conclusion. There are indeed many ways to conduct a meta-analysis. Therefore it is possible to 'dredge the data' in different ways until the most positive or negative result emerges, but importantly Shang had stated what his approach would be before embarking on the meta-analysis, and his approach seemed reasonable and unbiased. In other words, the
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137
research was impartial because the goalposts were decided before the data was examined, and the goalposts were of a fair size and were not moved once the research was under way. 3
H o m e o p a t h s point out that the meta-analysis included trials for several illnesses, which m a k e s it too crude to say anything meaningful
about h o m e o p a t h y ' s ability to treat individual
conditions. This over-arching meta-analysis was prompted by the fact that there has been no convincing evidence that homeopathy can treat any individual condition. Whenever researchers have conducted systematic reviews of homeopathy for a particular condition, the results have been consistently disappointing. For headaches and migraine: 'The trial data available to date do not suggest that homeopathy is effective.' For muscle soreness, the most tested condition: 'The published evidence to date does not support the hypothesis that homoeopathic remedies used in these studies are more efficacious than placebo.' For Arnica in the treatment of conditions associated with tissue trauma (e.g. postoperative or post-dental), which is the most widely used homeopathic remedy: 'The claim that homeopathic Arnica is efficacious beyond placebo is not supported by rigorous clinical trials.' 4
H o m e o p a t h s point out that they offer a highly individualized treatment, which is not suited to large-scale trials in which the homeopathic remedy is standardized. Indeed, most trials have not been individualized, but there have been trials in which patients were given detailed consultations and either individualized homeopathic prescriptions or placebo. For example, an individualized trial monitoring ninety-eight patients with chronic headaches over the course of twelve weeks led to the conclusion: 'There was no significant difference in any parameter between homeopathy and placebo.' Another trial focused on ninety-six children with asthma and looked at their progress after twelve months of receiving individualized homeopathy or a placebo as an adjunct to their
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TRICK OR TREATMENT?
conventional treatment. It concluded: 'This study provides no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo.' S h a n g ' s view of homeopathy is backed up by the C o c h r a n e Collaboration,
the
highly
respected,
independent
evaluator
of
medicines introduced in the previous chapter. T h e r e are C o c h r a n e reviews on homeopathy for the induction of labour and the treatment of dementia, chronic asthma and flu. C o c h r a n e ' s conclusions are based on sixteen trials involving over 5,000 patients. O v e r and over again, the evidence is either non-existent or shaky, leading to conclusions such as 'there is not e n o u g h evidence to reliably assess the possible role of homeopathy in a s t h m a ' ; 'current evidence does not support a preventative effect'; and 'there is insufficient evidence to r e c o m m e n d the use of homeopathy as a method of induction'. It is interesting to contrast the tenor of these c o m m e n t s on h o m e o pathy with C o c h r a n e ' s c o n c l u s i o n on a c o n v e n t i o n a l m e d i c i n e such as aspirin:
' A s p i r i n is an effective analgesic for acute pain of
m o d e r a t e to severe intensity with a clear d o s e - r e s p o n s e . ' M o r e o v e r , C o c h r a n e confirms h o w the efficacy of real m e d i c i n e is so robust that it can be tested in different w a y s :
' T y p e of pain m o d e l , pain
m e a s u r e m e n t , s a m p l e s i z e , quality of study d e s i g n , and
study
duration had no significant impact on the results.' T h i s is the sort of confident c o n c l u s i o n
that e m e r g e s
when
a genuinely
effective
m e d i c i n e is tested. Sadly, research into h o m e o p a t h y has failed to deliver any kind of positive c o n c l u s i o n .
Conclusions It has taken several thousand words to review the history of h o m e o pathy and to survey the various attempts to test its efficacy, but the conclusion is simple: hundreds of trials have failed to deliver significant or convincing evidence to support the use of h o m e o p a t h y for the treatment of any particular ailment. On the contrary, it would be fair to say that there is a mountain of evidence to suggest that homeopathic remedies simply do not work. This should not be such a surprising
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139
conclusion when we recall that they typically do not contain a single molecule of any active ingredient. This raises an interesting question: with no evidence that it works and with no reason w h y it ought to w o r k , w h y is it that homeopathy has grown so rapidly over the last decade into a multi-billion-dollar global industry? W h y do so m a n y people think that h o m e o p a t h y w o r k s , w h e n the e v i d e n c e , frankly, shows that it does not? O n e problem is that the public are unaware of the vast b o d y of research that undermines homeopathy. W h i l e L i n d e ' s original overly optimistic paper from 1997 is hyped on many p r o - h o m e o p a t h y w e b sites, there are far fewer mentions of his more equivocal
1999
re-analysis of exactly the same data. Similarly, the even more important and more negative 2005 paper by Shang is often omitted from homeopathy websites. Worse still, the public can be misled by n e w s stories that show homeopathy in an unjustifiably sympathetic light. O n e of the most high-profile h o m e o p a t h y n e w s stories in recent years concerned a study by the Bristol H o m o e o p a t h i c Hospital published in 2 0 0 5 . T h e hospital tracked 6,500 patients during a six-year study and observed that 70 per cent of those suffering with chronic diseases reported positive health changes after homeopathic treatment. As far as the public was concerned, this appeared to be an extraordinarily positive result. However, the study had no control g r o u p , so it was impossible to determine whether these patients would have improved without any homeopathic treatment. T h e 70 per cent improvement rate could have been due to any n u m b e r of factors, including natural healing processes, or patients being reluctant to disappoint w h o e v e r w a s interviewing them, or the placebo effect, or any other treatments that these patients m a y have been using. Science writer Timandra Harkness was one of many critics w h o tried to point out w h y the Bristol study was largely meaningless: 'It's as if you had a theory that feeding children nothing but cheese m a d e t h e m g r o w taller, so you fed all your children c h e e s e , measured them after a year and said There - all of them have grown taller - proof that cheese
works!'
We suggest that you ignore the occasional media h y p e and instead rely on our conclusion, because it is based on examining all the reliable
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TRICK OR TREATMENT?
evidence - and the evidence suggests that h o m e o p a t h y acts as nothing m o r e than a placebo. For this reason, we strongly advise you to avoid homeopathic remedies if you are looking for a medicine that is m o r e than just make-believe. Before ending this chapter, it is important to reiterate that we have c o m e to our conclusions about homeopathy based on a fair, thorough, scientific assessment of the e v i d e n c e . We have no axe to grind and have remained
steadfastly
open-minded
in
our e x a m i n a t i o n of
homeopathy. Moreover, one of us has had a considerable amount of experience in homeopathy and has even spent time practising as a h o m e o p a t h . After graduating from a conventional medical school, Professor Ernst then trained as a h o m e o p a t h . He even practised at the homeopathic hospital in M u n i c h , treating inpatients for a whole range of conditions. He recalls that the patients seemed to benefit, but at the time it was hard to determine whether this was due to homeopathy, the placebo effect, the dietary advice given by doctors, the b o d y ' s natural healing ability, or something else. Ernst continued to practise (and indeed receive) h o m e o p a t h y for many years, remaining open to its potential. If homeopathy could be shown to be effective, then he and his colleagues would have been overjoyed, as it would offer fresh h o p e for patients and present new avenues of research in medicine, biology, chemistry and even physics. Unfortunately, as Ernst took a step back and began to look at the research into this form of medicine, he became increasingly disillusioned. O n e key piece of research that helped to c h a n g e Ernst's view w a s conducted in 1991 by the G e r m a n pharmacologist Professor W. H. Hopff, w h o repeated H a h n e m a n n ' s original experiment with C i n c h o n a - according to H a h n e m a n n , if a medicine that cured malaria was given to a healthy volunteer, then it would actually generate the s y m p t o m s of malaria. Using his o w n students as guinea pigs, the professor c o m pared C i n c h o n a with a placebo and discovered no difference. Neither positive nor negative. In short, H a h n e m a n n ' s results, which provided the foundation for homeopathy, w e r e simply w r o n g . Such trials m a d e it clear to Ernst that homeopathic medicines are nothing m o r e than elaborate placebos. Nevertheless, s o m e readers might still feel that elaborate placebos
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are perfectly acceptable. You might feel that placebos help patients, and that this alone justifies the use of homeopathy. S o m e mainstream doctors sympathize with this view, while many others strongly disagree and feel that there are reasons why the placebo effect alone is not enough to justify the use of homeopathy in healthcare. For e x a m p l e , placebo treatments are not inevitably beneficial, and they can even endanger the health of patients. Even homeopathic r e m e d i e s , containing no active ingredients, can carry risks. We will discuss the issue of safety in homeopathy and in relation to other alternative therapies at the end of the next chapter. In the m e a n t i m e , we will end this chapter by briefly considering another negative aspect of using placebo-based treatments such as homeopathy, namely the cost. This issue has been highlighted by Professor David C o l q u h o u n , a pharmacologist w h o in 2006 criticized the sale of a homeopathic first-aid kit: All the 'remedies' in this kit are in the 30C dilution. They therefore contain no trace of the substance on the label. You pay £38.95 for a lot of sugar pills. To get even one molecule you'd have to swallow a sphere with a diameter equal to the distance from the Earth to the sun. That is hard to swallow. If a person is going to spend £38.95 on a first-aid kit, then surely it is better to spend the m o n e y on real medicines that are genuinely effective, as opposed to wasting it on fake m e d i c i n e s , such as homeopathy, which offer only a placebo benefit. Perhaps the most e x t r e m e e x a m p l e of a h o m e o p a t h i c rip-off is a r e m e d y called Oscillococcinum. T h e following paragraph, which is from an article published in the m a g a z i n e U.S. News and World Report in 1996, underlines
the
utter
absurdity
and
profiteering
that
underpins
the
homeopathic industry: Somewhere near Lyon, France, sometime this year, officials from the French pharmaceutical firm Boiron will slaughter a solitary duck and extract its heart and liver - not to appease the gods but to fight the flu. The organs will be used to make an over-the-counter flu medicine,
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TRICK OR TREATMENT?
called Oscillococcinum, that will be sold around the world. In a monetary sense, this single French duck may be the most valuable animal on the planet, as an extract of its heart and liver form the sole 'active ingredient' in a flu remedy that is expected to generate sales of $20 million or more. (For duck parts, that easily beats out foie gras in terms of return on investment.) How can Boiron claim that one duck will benefit so many sick people? Because Oscillococcinum is a homeopathic remedy, meaning that its active ingredients are so diluted that they are virtually nonexistent in the final preparation. In fact, the packaging boldly states that each g r a m of medication contains 0.85 grams of sucrose and 0.15 grams of lactose, which are both forms of sugar. In other w o r d s , Oscillococcinum is a self-declared 100 per cent sugar pill. R e m e d i e s free of active ingredients worth $20 million derived from a single duck? This has to be the ultimate form of medical quackery.
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The Truth About Chiropractic Therapy '. . . at the heart of science is an essential balance between
two seemingly contradictory attitudes - an
openness to new ideas, no matter how bizarre or counterintuitive,
and
the
most
ruthlessly
sceptical
scrutiny of all ideas, old and new. This is how deep truths are winnowed from deep nonsense.' Carl Sagan
Chiropractic Therapy A form of treatment developed at the end of the nineteenth century, which involves manual adjustments of the spine. Although some chiropractors focus on treating back pain, many others also treat a whole range of common illnesses, such as asthma. The underlying theory claims that manipulating the spine is medically beneficial because it can influence the rest of the body via the nervous system.
C H I R O P R A C T O R S , W H O USUALLY DEAL WITH BACK OR NECK PROBLEMS BY
manipulating the spine, are b e c o m i n g such an established part of the healthcare
s y s t e m that m a n y r e a d e r s will b e surprised t o see
chiropractic therapy included in a book about alternative medicine. After all, m a n y conventional doctors refer their patients to chirop r a c t o r s , a n d m a n y insurance plans are willing to c o v e r such treatments. This is particularly true in A m e r i c a , where chiropractors are most widespread, and where roughly $3 billion is spent annually on chiropractic treatment. As well as being an established part of the American healthcare system, chiropractors are b e c o m i n g increasingly popular - between 1970 and 1990 their n u m b e r s tripled, and in 2 0 0 2 there were 60,000 chiropractors practising in North America. It is expected that this figure will almost double by 2 0 1 0 , whereas the n u m ber of medical physicians will have increased by only 16 per cent. Perhaps the most significant indication that chiropractors have b e c o m e part of the medical mainstream is that they are licensed in all fifty US states, and they also have legal recognition in many other countries. For e x a m p l e , chiropractors in the United K i n g d o m are regulated by statute, which m e a n s that they have a similar standing to that of doctors and nurses. S o , bearing all this in m i n d , w h y do chiropractors deserve to be labelled as alternative therapists? T h e chiropractic approach to medicine emerged towards the end of the nineteenth century with a radically new view on health. T h e founders of chiropractic therapy argued that poor health w a s due to subluxations,
by
which
they
meant
slight
misalignments
of the
vertebrae in the spine. In turn, they believed that subluxations interfered with the flow of so-called innate intelligence (akin to a life force or vital energy), which then led to health problems of all sorts. But there is no evidence for the existence of innate intelligence or its role in health. T h e concepts of innate intelligence and subluxations are as
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mystical and as baffling as the concepts of C h ' i in acupuncture or extreme dilution in homeopathy, which means it makes no sense at all from a modern scientific point of view. That is w h y chiropractic treatment is still considered by many as an alternative medicine despite its current popularity. But, if we temporarily suspend disbelief and leave the underlying philosophy to one side, the key question is straightforward: does chiropractic therapy help patients? Fortunately, this is a question that has been addressed thanks to evidence-based medicine and the use of clinical trials. So far, evidence-based medicine has generated a pessimistic view of alternative medicine. Acupuncturists and h o m e o p a t h s have spent centuries developing treatments to help patients, and yet scientists have examined the e v i d e n c e , mainly from clinical trials, and concluded that these therapies are over-hyped. Acupuncture appears to be nothing more than a placebo for everything except s o m e types of pain and nausea, and the jury is out even for these conditions. Worse still, homeopathic remedies have failed to be more effective than placebos in the treatment of every k n o w n condition. S o m e readers m a y start to suspect that evidence-based medicine is s o m e h o w biased against alternative medicine. Perhaps acupuncture and homeopathy are actually valid therapies, and instead m a y b e it is in fact the clinical trial that is at fault? Perhaps the clinical trial is part of an establishment conspiracy cooked up by doctors and scientists to protect themselves from the interference of meddling outsiders? Just in case you are harbouring any such suspicions, let us take another look at the clinical trial and evidence-based medicine in general before examining the evidence for and against chiropractic therapy.
Evidence-based tea T h e core principle of the trial is simple and can be traced back as far as the thirteenth century, when the Holy R o m a n E m p e r o r Frederick II conducted an experiment to find out the effects of exercise on digestion. Two knights c o n s u m e d identical m e a l s , and then one went hunting while the other rested in bed. Several hours later, both knights
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TRICK OR TREATMENT?
were killed and the contents of their alimentary canals were e x a m i n e d . This revealed that digestion had progressed further in the sleeping knight. It was crucial to have two knights undergoing different levels of exercise, active and at rest, as it allowed the degree of digestion in one to be compared against the other. T h e key point of a trial is to c o m p a r e the consequences of t w o or more situations. T h e modern clinical trial, as developed by J a m e s Lind to test cures for scurvy in the eighteenth century, is less brutal than Frederick II's trial, but the central idea is the s a m e . If, for e x a m p l e , a novel treatment is to be tested, then it needs to be compared against something else, k n o w n as the control. That is w h y the novel treatment is given to one group of patients and the control is given to another group. T h e control can be an established treatment, or a placebo or anything at all. Afterwards the patients in both groups are assessed, so that the effect of the novel treatment can be compared against the control. Sir R o n Fisher, a British pioneer of the use of trials in the twentieth century, used to recount a story that amply demonstrated the simplicity and p o w e r of the trial. While at C a m b r i d g e , he b e c a m e embroiled in an argument over h o w to m a k e the ideal cup of tea. A w o m a n insisted that it tasted worse if milk was added to the tea as compared to when tea was added to the milk, but the scientists around the table argued that it made no difference at all. Fisher immediately proposed a trial - in this case the comparison was the taste of milk added to tea versus the taste of tea added to milk. Several cups were m a d e with milk added to the tea, and several with tea added to the milk, and the w o m a n was challenged to identify which was which. Although the cups of tea were prepared in secret and were identical in all other w a y s , the w o m a n could indeed correctly recognize in each case whether the tea had been added to the milk or vice versa. T h e trial had shown that there was a difference, that the w o m a n was right and that the scientists were w r o n g . In fact, there is a good scientific reason why the t w o forms of tea should taste different. Milk added to tea leads to a less satisfying c u p , because the milk b e c o m e s superheated and this causes proteins in the milk to deteriorate - these proteins then taste slightly sour. Fisher used this simple e x a m p l e as the basis for an entire book on
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scientific testing, The Design of Experiments, which went into great detail about the subtleties of trials. Despite its sheer simplicity and powerful ability to get to the truth, some alternative therapists argue that the clinical trial is a harsh test, which is s o m e h o w biased against their treatments. But that sort of attitude betrays a skewed understanding of the clinical trial, which merely seeks to establish the truth, regardless of the type of treatment being e x a m i n e d . In fact, the clinical trial provides a wholly unbiased and truly fair test of any medical treatment, either conventional or alternative. T h e unbiased nature of the clinical trial is demonstrated by the fact that the history of mainstream medicine is littered with apparently good ideas from conventional doctors that clinical trials proved to be useless or harmful. For e x a m p l e . Bill Silverman, an A m e r i c a n paediatrician w h o died in 2 0 0 4 , was a committed advocate of the clinical trial, even though he realized that it was a double-edged sword, capable of either validating or crushing any treatment. In 1949 he began working at the newly opened premature-infant station at the Babies Hospital in N e w York, and within a few weeks he was dealing with a premature baby suffering from a problem k n o w n as retinopathy of prematurity ( R O P ) , which can result in permanent blindness. The baby was the child of the hospital's biochemistry professor, w h o s e wife had previously had six miscarriages. As this w a s the first time that the professor's wife had successfully given birth, Silverman was particularly distressed at the prospect of the child b e c o m i n g blind. Grasping at straws, he decided to administer a newly discovered h o r m o n e known as A C T H (adrenocorticotropic h o r m o n e ) , which had not previously been used to treat newborn infants. Although it was a fairly hit-and-miss approach, with Silverman varying the dosage according to the b a b y ' s response, the end result was that she gained weight, her eyesight recovered and eventually she went h o m e happy and healthy. Inspired by this recovery, Silverman continued his A C T H treatment with subsequent cases of ROP. Furthermore, he compared his results with the recovery rates of babies with R O P at Lincoln Hospital, which was not offering A C T H treatment. T h e comparison w a s striking. Silverman gave A C T H to thirty-one babies suffering with R O P -
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TRICK OR TREATMENT?
twenty-five left with normal vision, t w o with near-normal vision, t w o with vision in just one eye and only t w o lost their sight completely. On the other h a n d , Lincoln Hospital had seven babies with R O P - they all lost their sight, except o n e . For m a n y doctors, the existing data - thirty-one babies treated with A C T H with a success rate of 80 per cent versus seven untreated babies with a recovery rate of only 14 per cent - would seem convincing e n o u g h . It would have been easy for Silverman to have continued with this therapy and r e c o m m e n d e d it to colleagues as a method for preventing blindness, but instead he had the humility and courage to question his o w n discovery. In particular, Silverman could see that his pilot study fell short of the rigour d e m a n d e d by a high-quality clinical trial. For e x a m p l e , the babies were not randomly assigned to the treatment or non-treatment g r o u p s , so m a y b e the babies at Lincoln Hospital were suffering from particularly serious problems, hence their lower recovery rate. Or maybe Lincoln Hospital's lack of success was a result of poorly trained staff or lack of equipment. Or maybe Lincoln Hospital was just unlucky - after all, the numbers involved were relatively small. To be confident about the efficacy of A C T H , Silverman decided to conduct a properly randomized controlled clinical trial. Premature babies with R O P were randomly assigned to an A C T H treatment group or a no-treatment control group within the same hospital. Both groups were treated identically, apart from the use or not of A C T H . Within a few m o n t h s the results emerged. An impressive 70 per cent of the infants treated with A C T H completely recovered their sight. Remarkably, the results in the control group were even more impressive, with an 80 per cent recovery rate. Babies in the untreated group had fared slightly better in terms of avoiding blindness, and moreover they suffered fewer fatalities compared to babies in the group treated with A C T H . It seemed that A C T H offered no benefit to babies and also had side-effects. A follow-up study confirmed the results of Silverman's rigorous clinical trial. T h e initial results from the Lincoln Hospital were abnormally poor, which had fooled Silverman into believing that he had discovered a powerful new treatment, but he had been wise enough not to be c o m placent and rest on his laurels. Instead, he re-tested his o w n hypothesis
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and disproved it. H a d he had not been so critical of his o w n w o r k , subsequent generations of paediatricians might have followed his example and administered A C T H , a useless, expensive and potentially harmful treatment. Silverman was a passionate believer in the randomized clinical trial as the tool for questioning and improving the care of babies, which m a d e him an unusual figure a m o n g doctors in the 1950s. Although researchers were convinced of the importance of evidence in determining best practice, the doctors on the ground still tended to be overconfident about their gut instincts. They had faith in their o w n sense of what the ideal conditions should be for helping premature babies, but according to Silverman this was a primitive way of deciding serious health issues: Like the approach taken by farmers caring for newborn piglets, conditions considered ideal for survival were provided, and it was assumed that those who were 'meant' to survive would do so. But none of these purportedly 'ideal conditions' had ever been subjected to formal parallel-treatment trials . . . almost everything we were doing to care for premature infants was untested. Doctors in the 1950s preferred to rely on what they had seen with their o w n e y e s , and would typically respond to patients with the mantra 'in my e x p e r i e n c e ' . It did not seem to matter to doctors that their personal experience might be limited or m i s r e m e m b e r e d , as o p p o s e d to the evidence from research trials, which w o u l d be extensive and meticulously d o c u m e n t e d . That is why Silverman was determined to instil a more systematic approach a m o n g his colleagues, and he was supported in his mission by his former tutor Richard Day: Like Dick, I was completely sold on the numerical approach; soon we were making nuisances of ourselves by criticizing the subjective 'inmy-experience' reasoning of our co-workers . . . I was increasingly aware that the statistical approach was anathema to free-wheeling doctors who resented any doubts being expressed about the effectiveness of their untested treatments.
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TRICK OR TREATMENT?
Half a century later, today's doctors are m u c h more accustomed to the concept of evidence-based m e d i c i n e , and most accept that a welldesigned randomized clinical trial is crucial for deciding what works and what does not. T h e purpose of this book has simply been to apply these same principles to alternative medicine. So what does evidencebased medicine say about chiropractic therapy?
Manipulating patients W h e n patients visit a chiropractor, they are usually suffering from back or neck pain. After taking a medical history, the chiropractor will e m b a r k on a thorough examination of the back, particularly the bones of the spine, called vertebrae. This will include looking at the patient's posture and overall mobility, as well as feeling along the spine to assess the symmetry and mobility of each spinal joint. Often X-ray images or M R I scans are also used to give a detailed view of the vertebrae. Any misalignment in the spine is then corrected in order to restore the patient's health. Chiropractors see the spinal column as a complex entity, such that each vertebra affects all the others. H e n c e , a chiropractor might work on a patient's upper spine or neck in order to treat pain in the lower back. The hallmark treatment of the chiropractor is a range of techniques k n o w n as spinal manipulation, which is intended to realign the spine in order to restore the mobility of j o i n t s . Chiropractors also call this an adjustment. It can be a fairly aggressive technique, which pushes the joint slightly beyond what it is ordinarily capable of achieving. O n e way to think about spinal manipulation is as the third of three levels of flexibility that can be achieved by a joint. T h e first level of flexibility is that which is possible with only voluntary m o v e m e n t . A second and higher level of flexibility can be achieved by exerting an external force, which pushes the joint until there is resistance. T h e third level of flexibility, which corresponds to spinal manipulation, involves a thrusting force that pushes the joint even further. T h e chiropractor will submit the vertebrae of the spine to this third level of motion by using a technique called high-velocity, low-amplitude thrust. This m e a n s that the chiropractor exerts a relatively strong force in order to m o v e the
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joint at speed, but the extent of the motion needs to be limited, because otherwise there would be d a m a g e to the joint and its surrounding structures. Although spinal manipulation is often associated with a cracking sound, this is not a result of the bones crunching against each other or a sign that bones are being put back in their right place. Instead, the noise is caused by the release and popping of gas b u b b l e s , which are generated when the fluid in the joint space is put under severe stress. If you have never visited a chiropractor, then the easiest way to imagine spinal manipulation is by analogy to an experiment you can do with your hand. Position your right forearm vertically u p w a r d s and hold your right hand flat, with the palm facing up - as if you are carrying a tray of drinks. Your wrist should be able to bend backwards so far that your flat hand begins to dip slightly below the horizontal this is what we have called level-one flexibility. If you use your left hand to press steadily and firmly d o w n w a r d s on your right p a l m , then the wrist can be bent a little further d o w n by a few d e g r e e s , which is level-two flexibility. Imagine - and please do not do this - that your left hand applied an additional short rapid thrust on your right hand, thus bending it d o w n even further by a small a m o u n t . This would be level-three flexibility, akin to the sort of action involved in spinal manipulation via a high-velocity, low-amplitude thrust. B e c a u s e spinal m a n i p u l a t i o n
is the t e c h n i q u e that generally
distinguishes chiropractors from other health professionals, it has been at the centre of efforts to establish the medical value of chiropractic therapy. Researchers have conducted dozens of clinical trials in order to evaluate spinal manipulation, but they have tended to generate conflicting results and have often been poorly designed. Fortunately, as with acupuncture and homeopathy, there have been several systematic reviews of these trials, in which experts have attempted to set aside the poor trials, focus on the best-quality trials and establish an overall conclusion that is reliable. In fact, there have been so many systematic reviews that in 2 0 0 6 Edzard Ernst and Peter Canter at Exeter University decided to take all of the current ones into account in order to arrive at the most up-to-date and accurate evaluation of chiropractic therapy. Published in the
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TRICK OR TREATMENT?
Journal of the Royal Society of Medicine, their paper was entitled
'A
systematic review of systematic reviews of spinal m a n i p u l a t i o n ' . Ernst and C a n t e r ' s review of recent reviews covered spinal manipulation in the context of a large range of conditions, but for the time being we will concentrate on the most c o m m o n p r o b l e m s dealt with by chiropractors, namely back and neck pain. In this context they took into account three reviews looking at back pain alone, t w o reviews looking at neck pain alone and one review that covered both neck and back pain. T h e individual reviews c a m e to varying conclusions. In the case of neck pain, two reviews concluded that spinal manipulation w a s ineffective, although one of them did find some evidence that chiropractic manipulation could be effective when used in combination with standard treatments. However, the combination effect is hard to disentangle, so it would be difficult to draw anything significant from this. The third review was more positive, concluding that spinal manipulation offered patients a moderate benefit, but it is worth noting that the lead author on this review was a chiropractor. Ernst and Canter had previously shown that chiropractors tend to generate more optimistic conclusions than scientists, perhaps because they have an emotional investment in the result. All in all, the evidence was insubstantial. For back pain, there was more of a consensus that spinal manipulation could be effective. Each review suggested that, on a v e r a g e , patients received benefit from the sort of treatments offered by chiropractors, but there was disagreement over the extent of that benefit and the evidence was not conclusive. T h e fact that chiropractic spinal manipulation might help with back pain is not a major milestone in the history of medicine - but it is particularly noteworthy in the context of this b o o k , because this is the most significant evidence so far that an alternative treatment might genuinely help patients. On the other hand, this conclusion should not be interpreted as an endorsement of chiropractors or a recommendation that patients with back pain should try spinal manipulation. T h e key question is not merely 'does spinal manipulation w o r k ? ' , but rather ' d o e s spinal manipulation work better than other forms of treatment?' Dealing
with
back
problems
is
notoriously
difficult,
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and
155
conventional medicine has struggled to develop truly effective treatm e n t s . In terms of dealing with the underlying p r o b l e m , doctors might r e c o m m e n d physiotherapy or exercise. A n d in terms of dealing with the s y m p t o m s , doctors often prescribe non-steroidal anti-inflammatory drugs ( N S A I D s ) , such as ibuprofen. These approaches are, however, only mildly or marginally effective. A truly life-changing cure for back pain has not yet b e e n found. W h e n the t w o approaches are compared against each other, spinal manipulation versus conventional m e d i c i n e , the result is that each is just about as effective (or ineffective) as the other. Indeed, this w a s one of the m a i n conclusions of Ernst and C a n t e r ' s review of reviews: spinal manipulation might help those w h o suffer with back pain, but c o n v e n t i o n a l
a p p r o a c h e s offer similarly m a r g i n a l
levels of
benefit. In a situation w h e r e t w o or more rival treatments m a t c h each other in terms of their effectiveness, there are several other deciding factors that determine which one is best. T h e simplest determining factor is often cost, which mitigates strongly against c h i r o p r a c t o r s , w h o generally charge a great deal for their services based on the misguided claim that their treatment is superior to conventional treatments. C o m p a r e ten sessions with a chiropractor at £ 5 0 each with regular exercise or ibuprofen, which are both relatively c h e a p , and the price difference b e c o m e s o b v i o u s . Furthermore, there are more important factors which also favour conventional treatment over chiropractic spinal manipulation. In fact, there are serious p r o b l e m s with chiropractic philosophy and practice, both of which should raise major concerns for prospective patients. These issues are closely linked to the early development of this form of treatment, so in order to appreciate t h e m properly we will take a historical detour and explore the origins of chiropractic therapy.
The bone-setting panacea T h e first documented account of manipulating the spine for therapeutic reasons dates back to Hippocrates in around 4 0 0 B C . In order to deal with back p r o b l e m s , he asked patients to lie face d o w n on a board and
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TRICK OR TREATMENT?
his assistants applied traction by pulling on the head and feet. At the same t i m e , Hippocrates pressed on the painful part of the spine, or sat on it, or bounced up and d o w n , or walked along it. We do not, by the way, r e c o m m e n d you try this at h o m e ! As the centuries passed, it b e c a m e the responsibility of specialists k n o w n as bone-setters to treat bones that w e r e b r o k e n , misaligned or dislocated. In N o r w a y the local bone-setter w a s often a first-born child, whereas in Ireland the bone-setter was typically the seventhb o r n , but birth order did not matter in Scotland as long as the person had been born feet first. Because bone-setters were not usually formally
educated
and
were
not
therefore
part
of the
medical
establishment, they often drew criticism from physicians. For e x a m p l e , Sarah M a p p , w h o was one of the most famous bone-setters in London in the 1730s, was nicknamed ' C r a z y Sally' by many physicians. Percival Pott, an eminent English surgeon w h o was the first to d e m o n strate that soot could cause cancer in c h i m n e y s w e e p s , went further and called her an 'ignorant, illiberal, d r u n k e n , female s a v a g e ' . On the other hand, Sir H a n s Sloane, w h o was President of the Royal College of Physicians, had sufficient respect for ' C r a z y Sally' to ask her to treat his niece's back injury. Chiropractic therapy, which emerged out of the bone-setting tradition, was founded by Daniel David Palmer, w h o was born near Toronto, C a n a d a , in 1845 and w h o moved to Iowa at the age of twenty. Palmer gradually developed an interest in m e d i c i n e , which included spiritual and magnetic healing, but his interest in the potential of spinal manipulation can be traced to a specific event that took place on 18 S e p t e m b e r 1895. Here is h o w Palmer later recorded the event: Harvey Lillard, a janitor in the Ryan Block, where 1 had my office, had been so deaf for 17 years that he could not hear the racket of a wagon on the street or the ticking of a watch. I made enquiry as to the cause of his deafness and was informed that when he was exerting himself in a cramped, stooping position, he felt something give in his back and immediately became deaf. An examination showed a vertebra racked from its normal position. I reasoned that if the vertebra was replaced, the man's hearing should be restored. With this object in view, a half
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hour talk persuaded Mr Lillard to allow me to replace it. I racked it into position by using the spinous process as a lever and soon the man could hear as before. On its o w n , this incident would not have started a revolution, but Palmer treated a second patient in a similar manner: Shortly after this relief from deafness, I had a case of heart trouble which was not improving. I examined the spine and found a displaced vertebra pressing against the nerves which innervate the heart. I adjusted the vertebra and gave immediate relief... Then I began to reason if two diseases, so dissimilar as deafness and heart trouble, came from impingement, a pressure on nerves, were not other diseases due to a similar cause? Thus the science (knowledge) and art (adjusting) of Chiropractic were formed at that time. I then began a systematic investigation for the cause of all diseases and have been amply rewarded. Palmer believed that he had stumbled upon a new medical technique. He was so convinced that chiropractic therapy offered a novel approach
to h e a l t h c a r e
that he o p e n e d the P a l m e r S c h o o l
of
Chiropractic in 1897 in Davenport, Iowa. His reputation and charisma rapidly attracted many students to the school, where the main teaching resource was a textbook entitled The Chiropractor's Adjuster, written by Palmer himself. This outlined every detail of his chiropractic therapy in its 1,000 p a g e s , including how Palmer c a m e to n a m e his new treatment: 'Rev. Samuel H. Weed of Portland selected for me at my request two Greek w o r d s , cheir and praxis, meaning when combined " d o n e by h a n d " , from which I coined the word "chiro-practic".' Perhaps the most surprising feature of P a l m e r ' s chiropractic therapy w a s its ambition. Having allegedly treated deafness and a heart condition by realigning the spine of his patients, he was confident that spinal manipulation could deal with all the ills of the human race. For Palmer, chiropractic therapy was not primarily about treating back p r o b l e m s . He explicitly wrote: 'Ninety-five per cent of all diseases are caused by displaced vertebrae.' This statement might seem shocking to u s , but it made perfect sense
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TRICK OR TREATMENT?
to Palmer, w h o viewed the spine as key to the health of the entire body. He was keenly aware that the spine provides the highway that connects the brain and the spinal cord to the rest of the body by way of the peripheral
nervous
system.
H e n c e , according to Palmer, displaced
vertebrae
would
i m p a c t on
particular neural
pathways,
negatively
influ-
ence the organs connected via this
pathway
and
thereby
cause diseases. Consequently, if
chiropractors
realigned
these displaced vertebrae then they could cure diseases: not
Daniel David Palmer
just deafness and heart disease, but also everything from measles to sexual dysfunction. This is already an extraordinary claim, and it appears even more bizarre when phrased in P a l m e r ' s o w n language. As mentioned earlier in the chapter, Palmer used the term 'subluxation' to describe a displacement in the spine, which resulted in a blockage of the b o d y ' s so-called 'innate intelligence'. He developed a theory whereby innate intelligence acted as the b o d y ' s guiding energy, carrying both metaphysical and physiological significance. This is why he believed that blocking its flow seriously disrupted the b o d y ' s h a r m o n y and could lead to all m a n n e r of diseases. It is important to stress that the term 'innate intelligence' is utterly meaningless beyond P a l m e r ' s unique view of the h u m a n body. On the other h a n d , the term 'subluxation' is used in orthodox m e d i c i n e , but has a meaning that has nothing to do with blocking innate intelligence. If a doctor talks about ' s u b l u x a t i o n ' , it simply m e a n s a partial dislocation of any joint, such as a twisted ankle. In short, P a l m e r ' s 'innate intelligence' and 'subluxation' carry no scientific significance.
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159
Figure 5 A chiropractic chart shows how each vertebra relates to different parts of the body and is responsible for various ailments.
This simplified chart shows the ailments corresponding to
only some of the vertebra. For example, a misaligned third lumber vertebra could cause bladder problems, and realignment could cure this.
When Palmer cured his first two patients,
he presumably manipulated the fourth cenical vertebra and the second thoracic vertebra, as these are linked with hearing loss and heart problems.
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TRICK OR TREATMENT?
T h e concept of innate intelligence w a s so strange that it s e e m e d as if chiropractic therapy w a s not only a n e w medical d o c t r i n e , but also a new
religion. I n d e e d , P a l m e r v i e w e d G o d as the U n i v e r s a l
Intelligence, guiding the totality of e x i s t e n c e , w h i c h m e a n t that innate intelligence represented G o d ' s guiding influence within the h u m a n body. In P a l m e r ' s o w n w o r d s , T am the founder of chiropractic in its s c i e n c e , in its art, in its p h i l o s o p h y and in its religious p h a s e ' . H e e v e n likened himself t o ' C h r i s t , M o h a m e d , J o . Smith [founder of the Latter D a y Saints m o v e m e n t ] , M r s . E d d y [founder of the Christian Science c h u r c h ] , Martin L u t h e r and otherfs] w h o h a v e founded r e l i g i o n s . ' Conventional doctors were suspicious of P a l m e r ' s quasi-religious philosophy, and they were particularly angered by his extraordinary claim that the spine w a s the root cause of disease and that spinal manipulation was the best way to cure patients. T h e y were annoyed by his boast that 'chiropractic is a science of healing without d r u g s ' , and they were alarmed by his refusal to acknowledge the role of germs in causing many of the diseases prevalent at the time. Not surprisingly, it was not long before there was a c a m p a i g n against Palmer, led by a local doctor named Heinrich Matthey. He accused Palmer of teaching an unproven medical concept and practising medicine without a licence. In fact, this led to Palmer being taken to court three times and on the third occasion, in 1906, he was sentenced to time in jail when he refused to pay a fine. If anything, this strengthened the fast-growing m o v e m e n t : chiropractic therapy had its first martyr, and many more would follow. D. D. P a l m e r ' s son was Bartlett Joshua Palmer, and it was he w h o continued to promote chiropractic therapy while his father w a s indisposed. He b e c a m e successful in his o w n right, so much so that he was able to buy the first car in Davenport, but unfortunately in 1913 he ran over his father at the Palmer School of Chiropractic h o m e c o m i n g parade. D. D. Palmer died just a few w e e k s later - officially the cause of the death was recorded as typhoid, but it seems more likely that his death was a direct result of injuries caused by his son. Indeed, there is speculation that this was not an accident, but rather a case of patricide. Father and son had b e c o m e bitter rivals over the
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161
leadership of the chiropractic m o v e m e n t . Also B . J . Palmer had always resented his father and the w a y that he had treated his family: When each of our sisters reached eighteen, they were driven out of home and onto the streets of Davenport to make their living any way they could . . . All three of us got beatings with straps until we carried welts, for which father was often arrested and spent nights in jail . . . Father was so deeply involved and so busy with thinking and writings on Chiropractic, he hardly knew he had any children. B.J.
Palmer,
who
already
led
the
Universal
Chiropractic
Association, became the new undisputed figurehead of the m o v e m e n t . He was a smart operator and shrewd entrepreneur. He rapidly accumulated a large fortune by teaching students and treating patients. On top of all t h i s , in
1924 he started a lucrative sideline in selling
neurocalometers, which supposedly helped chiropractors by detecting subluxations. Palmer was very proud of his invention and promoted it widely, but from a modern point of view we can see that it was clearly a worthless piece of technology. T h e neurocalometer contained nothing more than a simple thermocouple, which is a standard piece of electrical equipment designed to measure temperature. H e n c e , it would have been useless for detecting misalignments in the spine or pinched nerves. Although each neurocalometer cost less than $ 1 0 0 to build, he initially sold them for $1,150, and then he increased the price to $2,200. To put this figure into context, $2,200 would have been e n o u g h to buy a house in Iowa in the 1920s, and yet Palmer s o m e h o w persuaded over 2,000 graduates from his college and other chiropractors to buy his bogus invention. Not surprisingly, his customers ended up dissatisfied. An attorney acting on behalf of one of the disgruntled customers attempted to sue Palmer: 'In all our experience as practicing attorneys, nothing more closely resembling a fraud and a swindle has ever been brought to our personal attention than this proposition which your school is submitting to its graduates.' In such situations, Palmer would repair his reputation by promoting himself on W O C , one of A m e r i c a ' s pioneering radio stations, which he
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TRICK OR TREATMENT?
had established in 1922. Although it carried p r o g r a m m e s on a range of subjects, such as current affairs and cookery, it also broadcast lectures by Palmer as well as other p r o g r a m m e s directly related to chiropractic therapy. Its audience stretched across large parts of A m e r i c a and C a n a d a , and Palmer even claimed he had listeners in Scotland, S a m o a and at the North Pole. Thanks to his radio station and other clever marketing techniques, Palmer oversaw the growth of the chiropractic movement over the next few decades, not just in America but also in Europe. For example, the British Chiropractic Association was founded in 1925 and the European Chiropractors' Union formed in 1932, by which time there were 126 chiropractors in Britain, seventy-six across Norway, Denmark and Sweden, and a few dozen others in Ireland, Belgium and elsewhere. M e a n w h i l e , back in A m e r i c a , chiropractors were c o m i n g under increasing pressure from the medical establishment, w h i c h disapproved of their philosophy and m e t h o d s . Doctors continued to encourage the arrest of chiropractors for practising medicine without a licence, and by 1940 there had been over 15,000 prosecutions. Palmer strongly endorsed the Universal Chiropractic Association's policy of covering legal expenses and supporting m e m b e r s w h o had been arrested, which resulted in 80 per cent of chiropractors walking free from court. W h e n the legal route failed to d a m p e n chiropractic spirits, the American Medical Association ( A M A ) tried other tactics, which culminated in 1963 in the formation of the C o m m i t t e e on Quackery. Its secretary, H. Doyle Taylor, wrote a m e m o to the AM A Board of Trustees, which reaffirmed that the C o m m i t t e e on Quackery considered its prime mission to be the 'containment of Chiropractic and ultimately the elimination of Chiropractic.' T h e C o m m i t t e e ' s activities included lobbying to keep chiropractors outside the Medicare healthinsurance p r o g r a m m e , and arguing that chiropractic therapy should not be recognized by the US Office of Education. This antagonism might seem unreasonable, but r e m e m b e r that the medical establishment had several reasons for despising chiropractors. T h e s e included their belief in the unscientific notion of innate intelligence, their denial that bacteria and viruses cause many diseases,
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163
and their conviction that realigning a patient's spine could cure every ailment. On top of all this, conventional doctors were shocked by the fact that many chiropractors were fond of the E-meter, another bizarre diagnostic gadget. Invented in the 1940s by a chiropractor n a m e d Volney Mathison, the E-meter has a needle that swings back and forth across a scale when a patient holds on to two electrical contacts apparently this is e n o u g h to determine a patient's state of health. The E-meter was also widely used by the Church of Scientology, so much so that many Scientologists believe that it w a s invented by their founder L. Ron Hubbard. Unfortunately, the E-meter is nothing more than a piece of technical h o c u s - p o c u s , which is why in 1963 the US Food & Drug Administration seized more than 100 of them from the Founding Church of Scientology. In many w a y s , the E-meter bears a resemblance to the equally bogus neurocalometer, invented t w o decades earlier by B. J. Palmer. Conventional
doctors
were
kinesiology, a method invented in
equally
dismissive
of
applied
1964 by a chiropractor called
George J. G o o d h e a r t , w h o argued that diseases could be identified by manually testing the strength of muscle groups. A patient's muscles supposedly b e c o m e immediately stronger if a treatment is beneficial, or the muscles b e c o m e w e a k e r if the treatment is harmful, or if a toxin or allergen is brought close to the body. Typically, the patient holds out an arm and a tester pushes against it to feel the strength and steadiness of the resistance. This is, of course, a highly subjective m e a s u r e m e n t , and it is hard to imagine why it should have any medical value. Indeed, controlled trials show that the claims of applied kinesiology have no basis in reality. As far as the AM A w a s concerned, all these problems were c o m p o u n d e d by the ambition of many chiropractors to act as primary care givers. In other w o r d s , chiropractors argued that they could replace general practitioners because they could also offer regular c h e c k - u p s , long-term preventative treatments and cures for many conditions. In the 1950s and 1960s it w a s possible to find adverts for chiropractors with claims such as 'there are very few diseases, as they are understood today, which are not treatable by Chiropractic m e t h o d ' , or 'Correction and treatment of both acute and chronic
164
TRICK OR TREATMENT?
polio by chiropractic methods have been unusually successful.' T h e A M A continued to fight back with its concerted effort to eliminate the chiropractic profession, but in
1976 its c a m p a i g n
suddenly backfired. 'Sore T h r o a t ' , an a n o n y m o u s source within the A M A , leaked material that revealed the details and the extent of the A M A ' s c a m p a i g n , which prompted Chester A. Wilk, a chiropractor from C h i c a g o , to file an anti-trust lawsuit against the A M A . Wilk was arguing that the A M A ' s c a m p a i g n against chiropractors amounted to anti-competitive behaviour, and that the medical establishment was merely trying to corner the market in treating patients. After dragging on for over a d e c a d e , the lawsuit eventually ended in 1987. Judge Susan Getzendanner, w h o had presided over the case, ruled that the A M A had indeed acted unfairly against chiropractors: Evidence at the trial showed that the defendants took active steps, often covert, to undermine chiropractic educational institutions, conceal evidence of the usefulness of chiropractic care, undercut insurance programs for patients of chiropractors, subvert government inquiries into the efficacy of chiropractic, engage in a massive disinformation campaign to discredit and destabilize the chiropractic profession and engage in numerous other activities to maintain a medical physician monopoly over health care in this country. T h e A M A took the decision to the Supreme Court, but the appeal failed in 1990 and thereafter the A M A was forced to alter its attitude. For e x a m p l e , it could no longer discourage its m e m b e r s from collaborating with chiropractors. Although the medical establishment had fought against this m o v e , it had to acknowledge that it resulted in two undoubtedly
positive
outcomes.
First, t h o s e
doctors
who
collaborated with chiropractors persuaded many of them to be more sympathetic to the ideas of conventional medicine. Second, it also encouraged many chiropractors to rethink their attitude to their o w n chiropractic therapy. In fact, many chiropractors were already b e c o m ing increasingly disillusioned with the outlandish claims of their founding fathers. Although these practitioners were still committed to using chiropractic therapy to treat musculoskeletal p r o b l e m s , they
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165
were reluctant to treat other conditions and were suspicious about the concept of innate intelligence. In short, these rebel chiropractors adopted a more defined j o b description, namely back specialists. T h e y became k n o w n as mixers, because they were willing to mix traditional chiropractic therapy with elements of mainstream medicine. B y contrast, c h i r o p r a c t o r s w h o strictly a d h e r e d t o P a l m e r ' s philosophy were k n o w n as straights. T h e y firmly believed every word Palmer had preached, including his core belief that a perfectly aligned spine would guarantee the flow of the ' i n n a t e ' and thus promote wellbeing throughout the entire body. T h e split between straights and mixers soon became bitter, with straights accusing mixers of betraying the chiropractic m o v e m e n t , and mixers accusing straights of being quacks. In 1998 Lon M o r g a n , a mixer, openly expressed his antagonism towards straight chiropractors and their odd beliefs: 'Innate Intelligence clearly has its origins in borrowed mystical and occult practices of a bygone era. It remains untestable and unverifiable and has an unacceptably high penalty/benefit ratio for the chiropractic profession.' Similarly, according to Joseph C. Keating, a mixer and a chiropractic historian: ' S o long as we propound the " O n e cause, one c u r e " rhetoric of Innate, we should expect to be met by ridicule from the wider health science c o m m u n i t y . ' In response, straights have accused mixers of not being real chiropractors, because they do not accept P a l m e r ' s basis for chiropractic therapy. It is relatively easy to find out w h o is right - straights or mixers because the former set of chiropractors claims to cure everything and the latter restricts its ambitions to the back and neck. Ordeal by clinical trial is the obvious method for settling such an argument. In fact, many clinical trials have been conducted to test the impact of spinal manipulation on a range of conditions, and m a n y of these were covered within the review of reviews by Ernst and Canter, which was discussed earlier in this chapter. We have already considered their conclusions relating to back and neck pain, but now it is time to look at their other conclusions. Ernst and Canter looked at ten systematic reviews based on seventy trials that considered spinal manipulation as a treatment for h e a d a c h e s , period pains, infantile colic, asthma and allergies. Their conclusions
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TRICK OR TREATMENT?
were universally negative - there was no evidence to suggest that chiropractors could treat any of these conditions. This should not be very surprising, as there is no logical, rational or scientific reason w h y manipulating a patient's spine should treat, for e x a m p l e , allergies. Moreover, there is no evidence that a misaligned spine can cause any of these non-musculoskeletal conditions in the first place. Indeed, if spinal misalignments caused disease, then we would expect people with back pain to be more likely to suffer with other ailments, but in 1995 Donald Nansel and M a r k Szlazak at the Palmer College of Chiropractic found no sign of this in the vast body of published medical literature: ' T h e r e is not the slightest suggestion that patients suffering from severe primary mechanical low back pain, for instance, are more prone to develop higher incidences of prostate or
testicular
carcinoma,
colitis,
ovarian
cysts,
endometriosis,
pancreatitis, appendicitis, diabetes, melitis, or any other category of regionally or segmentally related organ disease.' In a follow-up study published t w o years later, the same researchers also failed to find any evidence that these diseases were more likely in 'patients with broken necks or broken b a c k s , or patients with entire hips or shoulders blown apart by shotgun b l a s t s ' . Although Ernst and C a n t e r ' s review of reviews does not cover the impact of chiropractic manipulation on every non-musculoskeletal condition, it would be reasonable to conclude that chiropractors can offer nothing to help patients suffering from non-musculoskeletal conditions in general. This is partly because chiropractic therapy has failed whenever it has been tested as a treatment for specific nonmusculoskeletal conditions, and it is partly because - and this is worth stressing again - there is no reason w h y spinal manipulation should help with conditions ranging from ear infections to irritable bowel syndrome. Bearing all this in mind, be
unwise
directly
to
visit a
the scientific evidence shows that it would
chiropractor for anything
other than
a problem
related to your back.
This might seem o b v i o u s , but several surveys suggest that between 11 per cent and 19 per cent of American chiropractic patients suffer from non-musculoskeletal conditions. These patients are attracted to
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167
these pointless treatments by practitioners w h o are willing to offer them. According to one survey, 90 per cent of A m e r i c a n chiropractors think that the therapy should not be limited to musculoskeletal conditions, and another survey suggests that 78 per cent of Canadian chiropractors share this opinion - this indicates that the majority of North American chiropractors have straight tendencies. T h e percentages in E u r o p e m a y be similar, particularly as supposedly responsible chiropractic bodies in European countries offer misleading information about the p o w e r of chiropractic therapy. F o r e x a m p l e , the General Chiropractic C o u n c i l , which oversees chiropractic therapy in Britain, publishes a leaflet entitled ' W h a t can I expect w h e n I see a c h i r o p r a c t o r ? ' , which states that chiropractic therapy can lead to an improvement
in
'some
types of asthma, headaches, including
migraine, and infant c o l i c ' . Yet it is well k n o w n that the evidence from trials fails to support these c l a i m s .
Some words of caution for patients In short, the scientific evidence suggests that it is only worth seeing a chiropractor if you have a back p r o b l e m . H o w e v e r , it is still important to be cautious. In particular, we will offer six pieces of advice that should be useful for anybody considering a visit to a chiropractor: 1
M a k e sure that your chiropractor is a mixer and not a straight. It would be unwise to be treated by a chiropractic fundamentalist, namely s o m e o n e w h o believes in subluxations, innate intelligence and the ability of spinal manipulation to cure all diseases. T h e terms 'straight' and ' m i x e r ' do not generally appear on a chiropractor's business card, so the best way to identify a straight is to ask about the range of conditions that he or she claims to treat - a straight chiropractor will offer treatments for respiratory conditions, digestive disorders, menstrual p r o b l e m s , ear infections, pregnancy-related conditions, infectious and parasitic conditions, dermatological diseases, acute urinary conditions and many other ailments.
168
TRICK OR TREATMENT?
2
If you visit a chiropractor and the p r o b l e m is not resolved within six sessions, or there is no ongoing significant i m p r o v e m e n t within six sessions, then be prepared to stop treatment and consult your doctor for advice. Chiropractors have a reputation for lengthy and expensive treatments, as demonstrated by a survey in 2 0 0 6 that monitored ninety-six patients with acute neck pain. Although the patients generally reported i m p r o v e m e n t s , the treatments required twenty-four visits on average, and in t w o cases there were m o r e than eighty treatment sessions. It is likely that the majority of these recoveries had little to do with the chiropractic intervention, but were largely the result of time and the b o d y ' s o w n natural healing processes.
3
Do not allow a chiropractor to become your primary healthcare provider, which might include preventative and maintenance treatments covering all health issues. In 1995, a survey showed that 90 per cent of American chiropractors considered themselves primary care providers, but they are rarely qualified to take on this role. Patients are often impressed by the fact that many chiropractors c a n y the title Doctor, but this does not mean that they have attended medical school. The title generally indicates Doctor of Chiropractic (DC), which merely means that a practitioner has completed a chiropractic course lasting four years.
4
Avoid chiropractors w h o rely on unorthodox techniques for d i a g n o s i n g p a t i e n t s , such as applied kinesiology and the E-meter, which were described earlier. Such techniques are usually e m p l o y e d by straight chiropractors.
5
C h e c k the reputation of your chiropractor before embarking on any treatment, because chiropractors are m o r e likely than medical doctors to be involved in malpractice. According to a survey conducted in California in 2 0 0 4 , chiropractors were twice as likely as m e d i c a l doctors to be the subject of disciplinary actions. Even more worrying, the incidence rate for fraud was nine times higher for chiropractors than for doctors,
THE TRUTH A B O U T CHIROPRACTIC THERAPY
169
and the rate for sexual boundary transgressions w a s three times higher for chiropractors than doctors. 6
Last, but not least, try conventional treatments before turning to a chiropractor for back pain. T h e y are generally cheaper than spinal manipulation and just as likely to be effective. There are also other reasons for following the conventional route, but we will c o m e to these later in the chapter. T h e advice above is based on serious and well-founded criticisms of
some elements of the chiropractic community. For e x a m p l e , chiropractors, particularly in America, have earned a reputation for zealously recruiting and unnecessarily treating patients. Practice-building seminars are commonplace and there are numerous publications aimed at helping chiropractors find and retain patients. In many cases the emphasis seems to be placed on economics rather than healthcare: the chiropractor Peter Fernandez is the author of a five-volume series called Secrets of a Practice-Building Consultant, which starts with a volume boldly titled 1,001 Ways to Attract Patients and ends with How to Become a Million Dollar a
Year Practitioner.
M a n y chiropractors are embarrassed by the zealous profiteering of their colleagues. For instance, G. Douglas A n d e r s o n , writing in Dynamic
Chiropractic, has
argued
that the chiropractic
movement
needs a radical overhaul: It is high time we admit there is nothing conservative, holistic or natural about endless care, creating addiction to manipulation, or making unsubstantiated, cure-all claims. On the contrary, an excellent argument can be made that the variety of tricks, techniques and claims still used by a large percentage of our profession to keep fully functional, asymptomatic people returning for care is fraudulent. A c c o r d i n g to Joseph C. K e a t i n g , himself a chiropractor, the tendency to profiteer and mislead can be traced back to the founders of the chiropractic therapy, particularly B . J . Palmer: ' I n d e e d , the profession, as a unified body politic, has never truly renounced the
170
TRICK OR TREATMENT?
marketing and advertising excesses modelled by B. J. and m a n y clinical procedures and innovations since are noteworthy for the extraordinary and unsubstantiated claims which are m a d e for t h e m . ' It seems that chiropractors are fond of manipulating their patients in both senses of the w o r d . Stephen Barrett, a US psychiatrist and medical writer, has b e e n at the forefront of criticizing and exposing other shady aspects of chiropractic therapy. For e x a m p l e , he conducted a small experiment to see h o w four chiropractors would diagnose and deal with the same healthy patient, a twenty-nine-year-old w o m a n : The first diagnosed 'atlas subluxation' and predicted 'paralysis in fifteen years' if this problem was not treated. The second found many vertebrae 'out of alignment' and one hip 'higher' than the other. The third said that the woman's neck was 'tight'. The fourth said that misaligned vertebrae indicated the presence of 'stomach problems'. All four recommended spinal adjustment on a regular basis, beginning with a frequency of twice a week. Three gave adjustments without warning - one of which was so forceful that it produced dizziness and a headache that lasted several hours. Barrett's
study
of chiropractors
was
neither exhaustive nor
definitive, but his limited sampling did suggest that there is something rotten at the heart of the chiropractic profession. Chiropractors dealing with the same healthy individual could agree on neither the diagnosis nor which part of the spine was problematic - all that they could agree on was that regular chiropractic therapy was the solution. Perhaps this should not be surprising when we bear in mind that the underlying principles of chiropractic therapy, the notions of subluxations and innate intelligence, are m e a n i n g l e s s . In addition to all this, and even more worrying, is Barrett's last sentence, which mentions
that his
u n d e r c o v e r patient
suffered
'dizziness and a headache that lasted several h o u r s ' . This raises an important issue that we have not yet discussed, namely safety. Every medical treatment should offer the likelihood of benefit, but it will also, almost inevitably, carry a likelihood of side-effects. T h e key issue
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171
for patients is simple: does the likely extent of the benefit outweigh the likely extent of the adverse side-effects, and h o w does this risk-benefit analysis c o m p a r e to other treatments? As we shall discuss below, the dangers of chiropractic therapy can be serious and in some cases life-threatening.
The dangers of chiropractic therapy Often the first hazard encountered when visiting a chiropractor is undergoing an X-ray examination, which seems to be a routine procedure a m o n g many practitioners. A survey conducted across Europe in 1994 revealed that 64 per cent of patients received X-rays when visiting a chiropractor, and a survey of m e m b e r s of the American Chiropractic Association conducted in the same year suggested that 96 per cent of new patients and 80 per cent of returning patients were X-rayed. Although many chiropractic publications explicitly advise against the routine use of X - r a y s , these surveys reveal an almost cavalier approach to a technology that does carry a risk of causing cancer. It is estimated that on average medical X-rays are responsible for 14 per cent of our annual exposure to radiation. M u c h of the remaining 86 per cent c o m e s from natural sources such as radon gas seeping up through the ground. T h e increased risk of cancer due to X-rays is small, but it is not negligible. According to a paper published in the Lancet in 2 0 0 4 , roughly
700 of the
124,000 new cancer cases
diagnosed each year in the UK are due to medical X-rays. Although X-rays therefore account for 0.6 per cent of new cancer c a s e s , they continue to be used widely in medicine because they offer tremendous benefits in terms of diagnosing and monitoring patients. In other w o r d s , conventional doctors are willing to use X-rays because the benefits outweigh the potential h a r m , but at the same time they minimize the use of X - r a y s , e m p l o y i n g t h e m only when there is a clear reason to do so. In contrast, chiropractors m a y X-ray the same patient several times a year, even though there is no clear evidence that X-rays will help the therapist treat the patient. X-rays can reveal neither the subluxations
172
TRICK OR TREATMENT?
nor the innate intelligence associated with chiropractic philosophy, because they do not exist. There is no conceivable reason at all why Xraying the spine should help a straight chiropractor treat an ear infection, asthma or period pains. Most worrying of all, chiropractors generally require a full spine X-ray, which delivers a significantly higher radiation dose than most other X-ray procedures. This raises the question of w h y so many chiropractors are so keen to X-ray their patients. Partly they are blindly following a corrupt methodology and a bankrupt philosophy that has been passed d o w n through the d e c a d e s , while ignoring the latest advice from experts. On top of this, it is important to r e m e m b e r that X-raying patients is a very lucrative part of any chiropractic business. In addition to the risk associated with X - r a y s , the actual manipulation of the spine can also have negative repercussions. In 2 0 0 1 , a systematic review of five studies revealed that roughly half of all chiropractic patients experience temporary adverse effects, such as p a i n , n u m b n e s s , stiffness, d i z z i n e s s and
h e a d a c h e s . T h e s e are
relatively minor adverse effects, but the frequency is very high, and this has to be weighed against the limited benefit offered by chiropractic therapy. More worryingly, patients can also suffer serious problems such as dislocations and fractures. These hazards are more likely and more dangerous for older patients, w h o may be suffering from osteoporosis. For instance, in
1992 the Journal of Manipulative and Physiological
Therapeutics reported the case of a seventy-two-year-old w o m a n w h o visited a chiropractor complaining of back pain. She received twentythree treatment sessions over the course of six w e e k s , which resulted in multiple spinal compression fractures. On top of all these risks, there is an even more serious hazard associated with chiropractic therapy. To appreciate this hazard, we need to refer back to Figure 5 on page 160, which shows the structure of the spine. It consists of five regions - the coccygeal region is at the base, followed by the sacral, lumbar and thoracic regions, with the cervical region at the top. The most severe risk relates to manipulation of the cervical region. There are seven vertebrae that m a k e up this region, running from the base of the neck to the back of the skull. This
THE TRUTH A B O U T CHIROPRACTIC THERAPY
173
is one of the most flexible parts in our body, but this flexibility comes at a cost. The region is hugely vulnerable as it carries all the lifelines be tw e e n the head and the body.
In
vertebrae
particular, are
in
these close
proximity to the two vertebral arteries, which are threaded through pairs of holes on either side of each vertebra. This is illustrated in Figure 6. Before supplying o x g e n rich
blood
to
the
brain,
e a c h artery t a k e s a sharp twist b e c a u s e of the structure of the t o p m o s t vertebra. Figure 6
T h i s kink in the arteries is
A circle shows how a vertebral artery makes a
perfectly natural and causes
sharp kink at the final vertebra.
no problems, except when the neck is stretched and
simultaneously turned in an e x t r e m e or sudden way. T h i s can occur w h e n c h i r o p r a c t o r s p e r f o r m their h a l l m a r k
high-velocity, low-
a m p l i t u d e thrust m a n i p u l a t i o n . Such an action can result in a so-called vertebral d i s s e c t i o n , which m e a n s that the inner lining of the artery b e c o m e s torn. Vertebral dissection can affect blood flow in four w a y s . First, a blood clot can form a r o u n d the d a m a g e d area, gradually blocking that section of the artery. S e c o n d , the clot can eventually b e c o m e d i s l o d g e d , be carried into the brain and block a distant part of the artery. T h i r d , blood can b e c o m e trapped b e t w e e n the inner and outer layers of the artery, w h i c h c a u s e s s w e l l i n g , thereby also r e d u c i n g the blood flow. F o u r t h , the injury to the artery can c a u s e it to go into s p a s m ; this m e a n s it contracts and effectively prevents blood flow. In all four situations, vertebral dissection can ultimately cut off the blood supply to s o m e parts of the b r a i n , which
174
TRICK OR TREATMENT?
in turn w o u l d lead to a stroke. In the most serious c a s e s , stroke can lead to p e r m a n e n t brain d a m a g e or death. Unfortunately, manipulating the cervical region is a c o m m o n practice a m o n g chiropractors, because it was promoted by B. J. Palmer as the most powerful chiropractic ' c u r e - a l l ' . Chiropractors have been oblivious to the d a m a g e that they might have been causing, because there is often a delay between the vertebral dissection and the blockage of blood to the brain. H e n c e , the link between chiropractic therapy and strokes went unnoticed for d e c a d e s . Recently, however, cases have been identified where manipulating the cervical region has certainly been the cause of vertebral dissection. O n e of the most clear-cut cases highlighting the dangers of spinal manipulation concerns Laurie M a t h i a s o n , a twenty-year-old C a n a d i a n , w h o visited a chiropractor twenty-one times between July 1997 and February 1998 in order to relieve her low back pain. On each occasion the chiropractor manipulated her cervical vertebrae, but after her penultimate visit she complained of pain and stiffness in her neck. That evening she b e c a m e clumsy, dropping ashtrays and plates at the restaurant where she w o r k e d , so she returned to the chiropractor the next day. As the chiropractor manipulated her neck once again, Laurie began to cry, her eyes started to roll, she foamed at the m o u t h , her body began to convulse and she turned blue. She was rushed to hospital, slipped into a c o m a and died three days later. T h e sudden and unusual nature of Laurie's death led to an inquest, with the aims of establishing the circumstances of her death and preventing similar tragedies in the future. After four days of e v i d e n c e , it s e e m e d that the
p e n u l t i m a t e chiropractic t r e a t m e n t had a l m o s t
certainly d a m a g e d Laurie's vertebral artery, which caused a blood clot in one of the arteries supplying her brain and led to the relatively mild effects she felt that evening. T h e final treatment then dislodged the blood clot, which subsequently travelled to Laurie's brain and killed her. T h e c o r o n e r ' s jury attributed Laurie's death to 'traumatic rupture of the left vertebral artery', and the coroner declared: ' S o at this point, the public k n o w s that Laurie died of a ruptured vertebral artery, which
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175
occurred in association with a chiropractic manipulation of the neck.' T h e jury also suggested a series of measures aimed at minimizing the risks to patients, which initially seemed to be well received by the senior figures in the chiropractic c o m m u n i t y . Unfortunately, this positive reaction from chiropractors rapidly evaporated, as they failed to implement the r e c o m m e n d a t i o n s of the inquest and began to deny responsibility for Laurie's death. T w o days after the inquest e n d e d , Paul Carey, president of the Canadian Chiropractic Protective Association, boldly stated on C B C Radio: ' T h e jury m e m b e r s did not m a k e a direct relationship to the chiropractic adjustment.' Just a few w e e k s later, a press release from the Canadian Chiropractic Association claimed: ' T h e jury did not make a finding that chiropractic treatment was the cause of this tragedy.' These statements were followed by chiropractic n e w s p a p e r s , newsletters, leaflets and advertisements that seemed to contradict the findings of the inquest, which only added to the grief felt by the Mathiason family. Laurie's mother, Sharon M a t h i a s o n , was openly critical when these pronouncements appeared: I say that what chiropractors are doing is waging a coordinated, intentional campaign of fraud and deceit on the Canadian public. This does not allow anyone who is contemplating going to a chiropractor to have a full and accurate truth about Laurie's death. People are not being properly informed of the risk of chiropractic. T h e case of Laurie Mathiason is certainly not unique. Indeed, in Canada alone there have been several other y o u n g w o m e n , such as Dora L a b o n t e , Lana Dale Lewis and Pierrette Parisien, w h o have died soon after receiving chiropractic manipulation of the neck. These highprofile cases have m a d e headlines and generated major discussions about the safety of chiropractic manipulation, but the key question is whether these tragedies are freak accidents, perhaps involving patients w h o were already vulnerable to strokes, or whether they are the tip of an iceberg, hinting at a widespread risk for all patients. There have been several attempts to assess the level of risk associated with chiropractic neck manipulation, and the one that is most
176
TRICK OR TREATMENT?
often quoted by chiropractors is a study entitled The Appropriateness of Manipulation
and Mobilization
of the
Cervical Spine.
Conducted
in
1996, it estimated that the n u m b e r of strokes, cord c o m p r e s s i o n s , fractures and large blood clots was 1.46 per million neck manipulations. This is a remarkably small risk, essentially one in a million, but it is misleadingly low for t w o reasons. First, experts suspect that the vast majority of incidents go unreported and unrecognized, so most incidents could not have been included in the study. S e c o n d , a patient may receive more than ten treatments for a particular condition, thus increasing the risk by a factor of m o r e than ten. Other surveys have suggested higher risks, and perhaps the most significant study was published by Canadian researchers in 2 0 0 1 , concluding that the risk of artery d a m a g e is one incident per 100,000 individuals receiving chiropractic neck manipulation. T h e y c o m p a r e d patients w h o had suffered d a m a g e to their vertebral arteries with control groups with no history of stroke. T h e results showed that patients under forty-five years of age w h o had suffered torn arteries were five times more likely to have visited a chiropractor in the week prior to the d a m a g e being recognized than healthy individuals of a similar age. This implies that chiropractic treatment can increase the risk of d a m a g e d arteries by a factor of five. O n e of us, Professor Ernst, has repeatedly reviewed the literature on the risks of spinal manipulation. To date, about 700 cases of serious complications have been d o c u m e n t e d in these publications. This should be a major concern for health officials, particularly as under-reporting will mean that the actual n u m b e r of cases is much higher. Indeed, if spinal manipulation were a drug with such serious and widespread adverse effects and so little demonstrable benefit, then it would almost certainly have been taken off the market by now. The risk of torn arteries caused by chiropractors, and the dire consequences of such d a m a g e , raises three serious criticisms of the chiropractic profession. First, it is surprising that the exact risk associated
with
spinal
manipulation
is
so
poorly
understood.
Chiropractors seem to have no system for recording and monitoring the d a m a g e that they may inadvertently cause, and therefore they seem to be avoiding any attempt to assess the safety of their profession. This
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problem was highlighted in 2 0 0 1 , when a team of researchers, including Edzard Ernst, asked m e m b e r s of the Association of British Neurologists to report cases of neurological complications referred to them that had occurred within twenty-four hours of neck manipulation. T h e y identified thirty-five c a s e s , which included nine strokes, over the course of one year. Ernst and his colleagues were shocked to find that n o n e of these cases had hitherto attracted any attention, inasmuch as they had not been reported in the medical literature or a n y w h e r e else. T h e approach of the chiropractic profession stands in stark contrast to the conventional medical establishment, which rigorously assesses the safety of drugs before they are m a d e publicly available. Even w h e n a drug is available for prescription, doctors are encouraged to continue to monitor and report any adverse incidents in order to identify any rare side-effects. In Britain, this p r o g r a m m e of ongoing vigilance is called the Yellow Card S c h e m e and it is administered by the Medical Healthcare Products Regulatory Agency ( M H R A ) . This and other methods are the reasons w h y we learn about hitherto u n k n o w n risks and why we can, if risks e m e r g e , withdraw a drug. Nothing remotely similar exists in the world of chiropractic. T h e second criticism of chiropractors is that they often fail to warn patients of the potential risks of their treatment. A study published by chiropractors in 2 0 0 5 assessed the consent policy a m o n g 150 randomly selected chiropractors in the United K i n g d o m , and it revealed that only 23 per cent always discussed serious risks with their patients before treatment. This contravenes the requirements of the Department of Health in the U K : 'Before you e x a m i n e , treat or care for competent adult patients you must obtain their c o n s e n t . .. Patients need sufficient information before they can decide whether to give their consent: for example information about the benefits and risks of the proposed treatment, and alternative treatments.' It also falls short of the C o d e of Practice of the British General Chiropractic Council: 'Before instituting any examination or treatment, a chiropractor shall ensure that informed consent to such treatment or examination has been given. Failure to obtain informed consent may lead to criminal or civil proceedings.' T h e third criticism is that chiropractors continue to offer treatments
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for non-musculoskeletal conditions, even though spinal manipulation can have no impact on these conditions. This is an issue of concern that has already been raised, but it b e c o m e s even m o r e problematic if we bear in mind the two previous criticisms. Not only is spinal manipulation useless in terms of treating, for e x a m p l e , asthma, but it also carries a potentially deadly risk and patients are not always informed of this. Earlier in this chapter we offered some words of caution to patients w h o might be considering seeing a chiropractor, but we would like to add to this advice in light of the serious risks that we have n o w outlined. For e x a m p l e , we have stated that chiropractic therapy can sometimes help with back p r o b l e m s , and therefore short-term treatment from a mixer chiropractor can be helpful, but we have also stated that chiropractors tend to be no better than conventional physiotherapists at treating such conditions. H e n c e , because physiotherapeutic exercise is a m u c h safer treatment than chiropractic manipulation, we would strongly r e c o m m e n d the former rather than the latter as the first choice. Another treatment option, which we would also r e c o m m e n d ahead of chiropractic therapy, is osteopathy. T h e origins of osteopathy are similar to those of chiropractic therapy, inasmuch as both emerged in North A m e r i c a at the end of the nineteenth century as the result of discoveries m a d e by charismatic mavericks. In the case of osteopathy, the founder was A n d r e w Taylor Still. He believed that manipulating bones in general, not just the spine, improved blood flow and enhanced the nervous system. Moreover, he argued that manipulating bones could enable the body to heal every possible illness! Although the traditional ambitions of both chiropractic therapy and osteopathy - manipulating the spine or bones in general can cure everything - are equally bizarre and misguided, we would advise the latter rather than the former for several reasons. First, osteopaths have largely shed the more bizarre beliefs and claims from their early days and are today more solidly grounded in science. S e c o n d , they usually employ gentler techniques which cause fewer adverse side-effects. Third, they use fewer X-rays and are less likely to e m p l o y untested diagnostic m e t h o d s . Fourth, they generally do focus on conditions
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relating to the spine and the musculoskeletal system, leaving other diseases to other specialists. Importantly, however, cranial osteopathy is not a treatment that we would r e c o m m e n d as there is no evidence at all that it w o r k s . Both osteopathy and cranial osteopathy are explained in more detail in the appendix. If you do still decide to visit a chiropractor, despite all our concerns and warnings, then we w o u l d very strongly r e c o m m e n d that you start your consultation by confirming that your chiropractor will not be manipulating your neck. Even if your problem relates to your lower back, it is still worth stressing that your neck should not be touched, as many chiropractors will manipulate the neck without informed consent in order to address a whole range of conditions. Indeed, Laurie Mathiason, w h o died in 1998, was having her neck manipulated even though she was concerned about a pain in her lower back. Finally, before ending this section on the risks of chiropractic therapy, it is important to stress that all the concerns that have been raised also apply to the treatment of children. M a n y parents feel that they are acting in their children's best interests by taking them to see a chiropractor, but they should be aware that they are exposing t h e m to the hazards of X - r a y s , temporary adverse reactions, spinal injuries and even stroke. In fact, the dangers to children are particularly worrying, because children's bones continue growing right to the end of their teenage years, so a chiropractor would be manipulating an immature spine. As with adults, many chiropractors are willing to treat children for wholly inappropriate conditions, such as asthma, bedwetting, clumsiness, ear infections, gastric p r o b l e m s , hyperactivity, i m m u n e - s y s t e m p r o b l e m s , learning disorders and respiratory p r o b l e m s . Chiropractors will claim to be able to treat such conditions, but we know that the evidence does not suggest that spinal manipulation can offer any benefit. Prompted by these sorts of unfounded claims, the journalists Paul Benedetti and Wayne MacPhail have investigated the issues surrounding children and chiropractic therapy, and they included their findings in
Spin Doctors:
The
Chiropractic Industry
Under Examination. T h e y
focused their attention on their native C a n a d a , where virtually all chiropractors deal with children, and where a significant fraction of
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parents seek out chiropractic treatment for their offspring. Indeed, according to a survey conducted in 2004 in Toronto, 31 per cent of children had been treated by a chiropractor. To find out what happens to children w h o visit a chiropractor, Benedetti and MacPhail arranged for a colleague to a c c o m p a n y an eleven-year-old-girl, k n o w n as Judy, to visit five chiropractors in the Toronto area in 2 0 0 1 . Judy w a s also examined by Dr John W e d g e , an experienced paediatric orthopaedic surgeon at Toronto's Hospital for Sick Children, w h o confirmed that she was 'a perfectly healthy girl'. T h e goal was to find out if the chiropractors would agree with Dr W e d g e ' s conclusion. T h e chiropractors were told that Judy was generally in good health, but that she suffered from a few e a r a c h e s , some mild headaches and allergies, and that there w a s concern about the possibility of asthma. O n e chiropractor examined Judy and agreed that she was fine and r e c o m m e n d e d no spinal manipulation, but the other four found a whole range of p r o b l e m s . Moreover, different chiropractors found different problems and gave conflicting diagnoses. According to Benedetti and MacPhail: ' T h e other four put her through a barrage of tests and found imbalances, partially locked vertebrae, asymmetry, uneven weight distribution, and a spinal column riddled from top to bottom with subluxations. They found subluxations in the upper, middle and lower spine, but not necessarily in the same vertebrae.' The chiropractors claimed that the subluxations that they had identified could lead to learning problems, digestive ailments and reproductive difficulties, and one of them claimed to detect signs of early osteoarthritis. Not surprisingly, these chiropractors recommended spinal adjustment, with one of them proposing immediate care in the form of six visits a week for two weeks, then three times a week for six weeks, followed by twice weekly visits until the problems had improved. T h e journalists transcribed the c o m m e n t s of the chiropractors. O n e suspected that J u d y ' s problems could be traced back to her birth: ' T h e surgeon or somebody grabbing her head, twisting it one way or the other. A lot of stress was created. I would estimate probably 85 to 95 per cent of all the problems I see in adults start from the process of delivery if you can believe it.'
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